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

Primary Purpose

Deep Vein Thrombosis, Pulmonary Embolism

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Apixaban
Unfractionated Heparin (UFH)
Warfarin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring DVT, PE, VTE

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Medical University Hospital
  • Toho University Sakura Medical Center
  • Kokura Memorial Hospital
  • Hiroshima General Hospital
  • Teine Keijinkai Hospital
  • Kanazawa Medical University Hospital
  • Yokohama Minami Kyousai Hospital
  • National Hospital Organization Yokohama Medical Center
  • Mie University Hospital
  • National Hospital Organization Okayama Medical Center
  • Kinki University Hospital
  • National Cerebral and Cardiovascular Center Hospital
  • St. Luke's International Hospital
  • Nihon University Itabashi Hospital
  • National Hospital Organization Tokyo Medical Center
  • Japanese Red Cross Musashino Hospital
  • Tokyo Medical University Hospital
  • Fukushima Medical University Hospital
  • Kumamoto University Hospital
  • Saiseikai Kumamoto Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban

UFH/Warfarin

Arm Description

Outcomes

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
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
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)
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)
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
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
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.

Full Information

First Posted
January 29, 2013
Last Updated
May 16, 2016
Sponsor
Pfizer
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01780987
Brief Title
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism
Keywords
DVT, PE, VTE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Title
UFH/Warfarin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
Intervention Type
Drug
Intervention Name(s)
Unfractionated Heparin (UFH)
Intervention Description
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Dosing for 24 weeks to target INR range between 1.5-2.5
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 24
Title
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
Description
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.
Time Frame
Baseline to Week 24
Title
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
Description
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.
Time Frame
Baseline to Week 24
Title
Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period
Description
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.
Time Frame
Baseline to Week 24
Title
Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
Description
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.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyusyu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Hiroshima General Hospital
City
Hatsukaichi
State/Province
Hiroshima
ZIP/Postal Code
738-8503
Country
Japan
Facility Name
Teine Keijinkai Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Kahoku-gun
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
Facility Name
Yokohama Minami Kyousai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0037
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama City
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Kinki University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center Hospital
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
St. Luke's International Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Japanese Red Cross Musashino Hospital
City
Musashino
State/Province
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0661024&StudyName=AStudy%20To%20Evaluate%20Safety%20And%20Eficacy%20Of%20Apixaban%20In%20Japanese%20Acute%20Deep%20Vein%20Thrombosis%20%28DVT%29%20And%20Pulmonary%20Embolism%20%28PE%29%20Patie
Description
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AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

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