AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
- Conditions
- Deep Vein ThrombosisPulmonary Embolism
- Interventions
- Registration Number
- NCT01780987
- Lead Sponsor
- Pfizer
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Acute symptomatic proximal DVT with evidence of proximal thrombosis
- Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UFH/Warfarin Unfractionated Heparin (UFH) - UFH/Warfarin Warfarin - Apixaban Apixaban -
- Primary Outcome Measures
Name Time Method 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 Baseline to Week 24 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
Name Time Method Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) Baseline to Week 24 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 Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period Baseline to Week 24 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) Baseline to Week 24 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 Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period Baseline to Week 24 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 Baseline to Week 24 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.
Trial Locations
- Locations (20)
Toho University Sakura Medical Center
🇯🇵Sakura, Chiba, Japan
Kokura Memorial Hospital
🇯🇵Kitakyusyu, Fukuoka, Japan
National Cerebral and Cardiovascular Center Hospital
🇯🇵Suita-shi, Osaka, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto, Japan
Teine Keijinkai Hospital
🇯🇵Sapporo, Hokkaido, Japan
Mie University Hospital
🇯🇵Tsu, MIE, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama City, Okayama, Japan
Kinki University Hospital
🇯🇵Osakasayama, Osaka, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Japanese Red Cross Musashino Hospital
🇯🇵Musashino, Tokyo, Japan
Yokohama Minami Kyousai Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kanazawa Medical University Hospital
🇯🇵Kahoku-gun, Ishikawa, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Hiroshima General Hospital
🇯🇵Hatsukaichi, Hiroshima, Japan
National Hospital Organization Yokohama Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
St. Luke's International Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-ku, Tokyo, Japan