Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00457002
First received: April 4, 2007
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.


Condition Intervention Phase
Venous Thrombosis
Pulmonary Embolism
Drug: Apixaban
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Major Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of All Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1, first dose of drug to last dose of drug plus 2 days ] [ Designated as safety issue: Yes ]
    Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).


Secondary Outcome Measures:
  • Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants [ Time Frame: Day 1 to last dose of parenteral study drug plus 1 day ] [ Designated as safety issue: No ]
    Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).

  • Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants [ Time Frame: Day 1 to last dose of parenteral study drug plus 1 day ] [ Designated as safety issue: No ]
    Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).

  • Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: Yes ]
    Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated PE With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period [ Time Frame: Intended Treatment Period ] [ Designated as safety issue: No ]
    A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

  • Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths) ] [ Designated as safety issue: Yes ]
    Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.

  • Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.

  • Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.

  • Mean Change From Baseline in Heart Rate in Treated Participants [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.

  • Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.

  • Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.

  • Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.

  • Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.

  • Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.

  • Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements [ Time Frame: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs) ] [ Designated as safety issue: Yes ]
    Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.

  • Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants [ Time Frame: Day 1 to last dose of study drug plus 2 days ] [ Designated as safety issue: Yes ]
    Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.


Enrollment: 6758
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg)

Drug: Apixaban

Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days

Other Name: BMS-562247
Active Comparator: Arm 2

While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)

Drug: Enoxaparin

Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days


  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and non-pregnant, non-breastfeeding women
  • 40 years or older
  • hospitalized with congestive heart failure or acute respiratory failure
  • infection (without septic shock)
  • acute rheumatic disorder
  • inflammatory bowel disease

Exclusion Criteria:

  • patients with venous thromboembolism (VTE)
  • active bleeding or at high risk of bleeding
  • unable to take oral medication
  • with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457002

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham Hospital
Birmingham, Alabama, United States, 35294
Heart Center Research, Llc
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85013
Az Pulmonary Specialists Ltd
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Fort Smith Lung Center
Fort Smith, Arkansas, United States, 72901
United States, California
Scripps Clinic/Scripps Health And Green Hospital
La Jolla, California, United States, 92037
Va Long Beach Healthcare System
Long Beach, California, United States, 90822
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Dr. Felt Medical Office
Oakland, California, United States, 94609
Stanford University
Stanford, California, United States, 94305
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
Research Alliance, Inc.
Clearwater, Florida, United States, 33756
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States, 32216
Pensacola Lung Group
Pensacola, Florida, United States, 32504
Indian River Med. Ctr.
Vero Beach, Florida, United States, 32960
United States, Georgia
Pulmonary & Critical Care Of Atlanta
Atlanta, Georgia, United States, 30342
Atlanta Institute For Medical Research, Inc
Atlanta, Georgia, United States, 30030
United States, Idaho
Idaho Falls Infectious Diseases, Pllc
Idaho Falls, Idaho, United States, 83404
United States, Illinois
West Suburban Hospital
Oak Park, Illinois, United States, 60302
United States, Indiana
Infectious Disease Of Indiana Psc
Carmel, Indiana, United States, 46032
United States, Kansas
Cotton-O-Neil Clinical Research Center
Topeka, Kansas, United States, 66604
United States, Louisiana
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maryland
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States, 21205
United States, Michigan
Henry Ford Hospital, Transplant Institute
Detriot, Michigan, United States, 48202
United States, Missouri
University Of Missouri-Columbia
Columbia, Missouri, United States, 65212
United States, Montana
Mercury Street Medical Group, Pllc
Butte, Montana, United States, 59701
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Morristown Memorial Hospital
Mornstown, New Jersey, United States, 07962
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Mission Hospital, Inc
Asheville, North Carolina, United States, 28801
United States, Oklahoma
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States, 73135
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
The Milton S Hershey Medical Center Of Penn. State Univ.
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Palmetto Nephrology Pa
Orangeburg, South Carolina, United States, 29118
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Texas Health Presbyterian Dallas
Dallas, Texas, United States, 75231
Michael E. De Bakey Veteran Affairs Medical Center
Houston, Texas, United States, 77030
Sonterra Clinical Research
San Antonio, Texas, United States, 78258
Sonterra Clinical Research
San Antonio, Texas, United States, 78205
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
University Of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Mcguire Va Medical Center
Richmond, Virginia, United States, 23249
Argentina
Local Institution
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1280AEB
Local Institution
Coronel Suarez, Buenos Aires, Argentina, B7540GHD
Local Institution
Derqui-Pilar, Buenos Aires, Argentina, B1629ODT
Local Institution
La Plata, Buenos Aires, Argentina, 1900
Local Institution
Munro, Buenos Aires, Argentina, B1605DSX
Local Institution
San Martin, Buenos Aires, Argentina, B1650CSQ
Local Institution
Rosario, Santa Fe, Argentina, 2000
Local Institution
Rosario, Santa Fe, Argentina, S2002KDS
Local Institution
San Miguel De Tucuman, Tucuman, Argentina, T4000JCU
Local Institution
Buenos Aires, Argentina, C1181ACH
Local Institution
Cordoba, Argentina, X5006IKK
Local Institution
Cordoba, Argentina, 5000
Local Institution
Corrientes, Argentina, 3400
Australia, New South Wales
Local Institution
Concord, New South Wales, Australia, 2139
Local Institution
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Local Institution
Kippa Ring, Queensland, Australia, 4021
Local Institution
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Local Institution
Bedford Park, South Australia, Australia, 5042
Local Institution
Woodville, South Australia, Australia, 5011
Australia, Victoria
Local Institution
Box Hill, Victoria, Australia, 3128
Local Institution
Parkville, Victoria, Australia, 3050
Local Institution
Ringwood East, Victoria, Australia, 3135
Austria
Local Institution
Graz, Austria, 8036
Local Institution
Wien, Austria, 1090
Belgium
Local Institution
Ottignies, Waals-Brabant, Belgium, 1340
Local Institution
Antwerpen, Belgium, 2060
Local Institution
Brasschaat, Belgium, 2930
Local Institution
Bruxelles, Belgium, 1070
Local Institution
Huy, Belgium, 4500
Local Institution
Leuven, Belgium, 3000
Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil, 30150
Local Institution
Curitiba, Parana, Brazil, 80010
Local Institution
Curitiba, Parana, Brazil, 80810
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 91430
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90020
Local Institution
Botucatu, Sao Paulo, Brazil, 18618
Local Institution
Campinas, Sao Paulo, Brazil, 13059
Local Institution
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15091
Local Institution
Sao Paulo, Brazil, 04012
Local Institution
Sao Paulo, Brazil, 05403
Local Institution
Sao Paulo, Brazil, 04020
Local Institution
Sao Paulo, Brazil, 04025
Canada, Ontario
Local Institution
Ajax, Ontario, Canada, L1S 7K8
Local Institution
Hamilton, Ontario, Canada, L8N 3Z5
Local Institution
Hamilton, Ontario, Canada, L8N 4A6
Local Institution
Windsor, Ontario, Canada, N9A 1C9
Local Institution
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Local Institution
Granby, Quebec, Canada, J2G 1T7
Local Institution
Greenfield Park, Quebec, Canada, J4V 2H1
Local Institution
Montreal, Quebec, Canada, H1T 2M4
Local Institution
Montreal, Quebec, Canada, H2L 4M1
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Chile
Local Institution
Temuco, Araucania, Chile, - - - - -
Local Institution
Santiago, Metropolitana, Chile, 7500922
Local Institution
Santiago, Metropolitana, Chile, 8207257
Local Institution
Rancagua, Valparaiso, Chile, -----
Colombia
Local Institution
Bogota, Colombia, -----
Local Institution
Bucaramanga, Colombia, -----
Local Institution
Medellin, Colombia, -----
Czech Republic
Local Institution
Brno, Czech Republic, 656 91
Local Institution
Jindrichuv Hradec, Czech Republic, 377 38
Local Institution
Kladno, Czech Republic, 272 59
Local Institution
Kyjov, Czech Republic, 697 01
Local Institution
Ostrava, Czech Republic, 728 80
Local Institution
Prague 2, Czech Republic, 128 08
Local Institution
Praha 1, Czech Republic, 110 00
Local Institution
Praha 5, Czech Republic, 150 06
Local Institution
Usti Nad Labem, Czech Republic, 401 13
Denmark
Local Institution
Aalborg, Denmark, 9100
Local Institution
Aarhus N, Denmark, 8200
Local Institution
Arhus C, Denmark, 8000
Local Institution
Frederiksberg, Denmark, 2000
Local Institution
Glostrup, Denmark, 2600
Local Institution
Hellerup, Denmark, 2900
Local Institution
Herlev, Denmark, 2730
Local Institution
Herning, Denmark, 7400
Local Institution
Hvidovre, Denmark, 2650
Local Institution
Odense, Denmark, 5000
Local Institution
Randers No, Denmark, 8930
Local Institution
Silkeborg, Denmark, 8600
France
Local Institution
Bordeaux, France, 33075
Local Institution
Brest, France, 29200
Local Institution
Brest Cedex, France, 29609
Local Institution
Dijon Cedex, France, 21079
Local Institution
Grenoble Cedex 9, France, 38043
Local Institution
Lille Cedex, France, 59020
Local Institution
Nancy, France, 54035
Local Institution
Nimes Cedex 9, France, 30029
Local Institution
Paris Cedex 10, France, 75475
Local Institution
Paris Cedex 15, France, 75908
Local Institution
Saint Etienne Cedex 02, France, 42055
Local Institution
Vernon, France, 27207
Germany
Local Institution
Bonn, Germany, 53127
Local Institution
Coburg, Germany, 96450
Local Institution
Darmstadt, Germany, 64283
Local Institution
Dresden, Germany, 01099
Local Institution
Dresden, Germany, 01307
Local Institution
Hannover, Germany, 30625
Local Institution
Karlsbad, Germany, 76307
Local Institution
Luebeck, Germany, 23538
Local Institution
Mannheim, Germany, 68167
Local Institution
Offenbach, Germany, 63069
Local Institution
Witten, Germany, 58455
Hong Kong
Local Institution
Shatin, N.T., Hong Kong, -----
Hungary
Local Institution
Budapest, Hungary, 1135
Local Institution
Debrecen, Hungary, 4032
Local Institution
Dunaujvaros, Hungary, 2400
Local Institution
Eger, Hungary, 3300
India
Local Institution
Vishakapatnam, Andhra-Pradesh, India, 530002
Local Institution
Hyderabad, Andra Pradesh, India, 500004
Local Institution
Ahemdabad, Gujarat, India, 380054
Local Institution
Bangalore, Karnataka, India, 560034
Local Institution
Indore, Madhya Pardesh, India, 452018
Local Institution
Pune, Maharashtra, India, 411004
Local Institution
Pune, Maharashtra, India, 411001
Local Institution
Pune, Maharastra, India, 411001
Local Institution
Ludhiana, Punjab, India, 141001
Local Institution
Coimbatore, Tamil Nadu, India, 641004
Local Institution
Madurai, Tamil Nadu, India, 625107
Local Institution
Chennai, Tamil-Nadu, India, 600096
Local Institution
Noida, Uttar Pradesh, India, 201301
Local Institution
Ahmedabad, India, 380054
Local Institution
Bangalore, India, 560054
Local Institution
Bangalore, India, 560017
Local Institution
Hyderabad, India, 500033
Local Institution
Mumbai, India, 400008
Local Institution
New Delhi, India, 110025
Israel
Local Institution
Afula, Israel, 18101
Local Institution
Ashkelon, Israel, 78308
Local Institution
Beer Sheva, Israel, 84105
Local Institution
Haifa, Israel, 31096
Local Institution
Petach Tikva, Israel, 49100
Local Institution
Safed, Israel, 13110
Local Institution
Tel Hashomer, Israel, 52621
Local Institution
Tel-Aviv, Israel, 64239
Local Institution
Zerifin, Israel, 70300
Italy
Local Institution
Chieti Scalo, Italy, 66013
Local Institution
Cremona, Italy, 26100
Local Institution
Padua, Italy, 35128
Local Institution
Piacenza, Italy, 29100
Local Institution
Reggio Emilia, Italy, 42100
Local Institution
Treviso, Italy, 31100
Local Institution
Vicenza, Italy, 36100
Korea, Republic of
Local Institution
Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701
Local Institution
Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 463-707
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of, 136-705
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 137-040
Local Institution
Suwon, Korea, Republic of, 443721
Malaysia
Local Institution
Kubang Kerian, Kelantan, Malaysia, 16150
Local Institution
Batu Caves, Selangor, Malaysia, 68100
Local Institution
Johor Bahru, Malaysia, 80100
Mexico
Local Institution
Mexico, Distrito Federal, Mexico, 06726
Local Institution
Mexico, Distrito Federal, Mexico, 07760
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Xalapa, Veracruz, Mexico, 91020
Local Institution
Merida, Yucatan, Mexico, 97129
Local Institution
Queretaro, Mexico, 76178
Local Institution
San Luis Potosi, Mexico, 78220
Netherlands
Local Institution
Den Helder, Netherlands, 1782 GZ
Norway
Local Institution
Kongsvinger, Norway, 2226
Peru
Local Institution
La Victoria, Lima, Peru, LIMA 13
Local Institution
Arequipa, Peru, AREQUIPA54
Local Institution
Callao, Peru, CALLAO 2
Local Institution
Lima, Peru, LIMA 1
Local Institution
Lima, Peru, LIMA 01
Local Institution
Lima, Peru, LIMA 31
Local Institution
Lima, Peru, LIMA 1
Local Institution
Lima, Peru, LIMA 11
Philippines
Local Institution
Cagayan De Oro City, Misamis Oriental, Philippines, 9000
Local Institution
Las Pinas, Philippines, 1742
Local Institution
Quezon City, Philippines, 1110
Local Institution
Quezon City, Philippines, 1100
Local Institution
Quezon City, Philippines, 1102
Poland
Local Institution
Bydgoszcz, Poland, 85-168
Local Institution
Krakow, Poland, 31-202
Local Institution
Lodz, Poland, 91-347
Local Institution
Nowa Sol, Poland, 67-100
Local Institution
Poznan, Poland, 61-833
Local Institution
Skierniewice, Poland, 96-100
Local Institution
Warszawa, Poland, 03-737
Local Institution
Warszawa, Poland, 01-138
Local Institution
Wejherowo, Poland, 84-200
Local Institution
Zielona Gora, Poland, 65-046
Russian Federation
Local Institution
Moscow, Russian Federation, 121309
Local Institution
Moscow, Russian Federation, 119991
Local Institution
Moscow, Russian Federation, 117593
Local Institution
Moscow, Russian Federation, 117292
Local Institution
Moscow, Russian Federation, 111539
Local Institution
Moscow, Russian Federation, 129336
Local Institution
Moscow, Russian Federation, 115280
Local Institution
Moscow, Russian Federation, 127018
Local Institution
Odintsovo, Russian Federation, 143000
Local Institution
Podolsk, Russian Federation, 142100
Local Institution
Ryazan, Russian Federation, 390005
Local Institution
Saint Petersburg, Russian Federation, 199106
Local Institution
Saint-Petersburg, Russian Federation, 198205
Local Institution
Saratov, Russian Federation, 410002
Local Institution
Saratov, Russian Federation, 410054
Local Institution
St Petersburg, Russian Federation, 195067
Local Institution
St. Petersburg, Russian Federation, 193312
Local Institution
St.Petersburg, Russian Federation, 192242
Singapore
Local Institution
Singapore, Singapore, 308433
Local Institution
Singapore, Singapore, 529889
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9301
Local Institution
Johannesburg, Gauteng, South Africa, 2193
Local Institution
Pretoria, Gauteng, South Africa, 0044
Local Institution
Amanzimtoti, Kwa Zulu Natal, South Africa, 4120
Local Institution
Bellville, Western Cape, South Africa, 7530
Local Institution
Groenkloof, South Africa, 0181
Spain
Local Institution
Torrevieja, Alicante, Spain, 03186
Local Institution
Alcorcon(Madrid), Spain, 28922
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08003
Local Institution
Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28046
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28006
Local Institution
Madrid, Spain, 28007
Local Institution
Sevilla, Spain, 41013
Local Institution
Tarragona, Spain, 43007
Sweden
Local Institution
Goteborg, Sweden, 413 45
Local Institution
Lund, Sweden, 221 85
Taiwan
Local Institution
Yung-Kang City, Tainan, Taiwan, 710
Local Institution
Taichung, Taiwan, 402
Turkey
Local Institution
Istanbul, Capa, Turkey, 34390
Local Institution
Ankara, Dikimevi, Turkey, 06100
Local Institution
Istanbul, Turkey, 34390
Ukraine
Local Institution
Donetsk, Ukraine, 83003
Local Institution
Kharkiv, Ukraine, 61018
Local Institution
Kharkiv, Ukraine, 61176
Local Institution
Kharkov, Ukraine, 61039
Local Institution
Kyiv, Ukraine, 02091
Local Institution
Kyiv, Ukraine, 03151
Local Institution
Kyiv, Ukraine, 03115
Local Institution
Kyiv, Ukraine, 03680
Local Institution
Kyiv, Ukraine, 01133
Local Institution
Kyiv, Ukraine, 04050
Local Institution
Kyiv, Ukraine, 04201
Local Institution
Lutsk, Ukraine, 43024
Local Institution
Lviv, Ukraine, 79010
Local Institution
Uzhgorod, Ukraine, 88000
Local Institution
Vinnitsa, Ukraine, 21029
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW3 6LR
Local Institution
London, Greater London, United Kingdom, SE5 9RS
Local Institution
Uxbridge, Middlesex, United Kingdom, UB8 3NN
Local Institution
Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
Local Institution
Dudley, West Midlands, United Kingdom, DY1 2HQ
Local Institution
Hull, Yorkshire, United Kingdom, HU3 2JZ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00457002     History of Changes
Other Study ID Numbers: CV185-036
Study First Received: April 4, 2007
Results First Received: April 14, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014