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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

April 4, 2007
May 14, 2014
June 2007
May 2011   (final data collection date for primary outcome measure)
  • 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).
Composite of venous thromboembolism (VTE) and VTE-related death during 30 days of double-blind treatment.
Complete list of historical versions of study NCT00457002 on ClinicalTrials.gov Archive Site
  • 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.
Secondary outcomes include all cause death, major bleeding, and clinically relevant non-major bleeding during 30 days of double-blind treatment.
Not Provided
Not Provided
 
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Venous Thrombosis
  • Pulmonary Embolism
  • Drug: Apixaban

    Apixaban: Twice daily, 30 days

    Placebo: Once daily, 6-14 days

    Other Name: BMS-562247
  • Drug: Enoxaparin

    Enoxaparin: Once daily, 6-14 days

    Placebo: Twice daily, 30 days

  • 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)

    Intervention: Drug: Apixaban
  • Active Comparator: Arm 2

    While hospitalized, Enoxaparin plus Placebo

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

    After hospital discharge: Placebo

    Placebo (Tablets, Oral)

    Intervention: Drug: Enoxaparin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6758
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Peru,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom
 
NCT00457002
CV185-036
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP