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AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01780987
First received: January 29, 2013
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)

Condition Intervention Phase
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Apixaban
Drug: Unfractionated Heparin (UFH)
Drug: Warfarin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition] or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.


Secondary Outcome Measures:
  • Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. "Intended Treatment Period" was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late.

  • Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.

  • Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.

  • Number of Participants With Adjudicated Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition]During the Treatment Period [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.

  • Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis [ISTH] Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.


Enrollment: 80
Study Start Date: January 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban Drug: Apixaban
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
Active Comparator: UFH/Warfarin Drug: Unfractionated Heparin (UFH)
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
Drug: Warfarin
Dosing for 24 weeks to target INR range between 1.5-2.5

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute symptomatic proximal DVT with evidence of proximal thrombosis
  • Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches

Exclusion Criteria:

  • Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
  • Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
  • Subjects requiring dual anti-platelet therapy
  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: NCT01780987

Locations
Japan
Aichi Medical University Hospital
Nagakute, Aichi, Japan, 480-1195
Toho University Sakura Medical Center
Sakura, Chiba, Japan, 285-8741
Kokura Memorial Hospital
Kitakyusyu, Fukuoka, Japan, 802-8555
Hiroshima General Hospital
Hatsukaichi, Hiroshima, Japan, 738-8503
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan, 006-8555
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa, Japan, 920-0293
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa, Japan, 236-0037
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan, 245-8575
Mie University Hospital
Tsu, MIE, Japan, 514-8507
National Hospital Organization Okayama Medical Center
Okayama City, Okayama, Japan, 701-1192
Kinki University Hospital
Osakasayama, Osaka, Japan, 589-8511
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka, Japan, 565-8565
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan, 104-8560
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan, 152-8902
Japanese Red Cross Musashino Hospital
Musashino, Tokyo, Japan, 180-8610
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Saiseikai Kumamoto Hospital
Kumamoto, Japan, 861-4193
Sponsors and Collaborators
Pfizer
Bristol-Myers Squibb
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01780987     History of Changes
Other Study ID Numbers: B0661024  CV185160 
Study First Received: January 29, 2013
Results First Received: January 20, 2016
Last Updated: May 16, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
DVT
PE
VTE

Additional relevant MeSH terms:
Thrombosis
Embolism
Venous Thrombosis
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Apixaban
Calcium heparin
Heparin
Warfarin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016