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Trial record 1 of 1 for:    NCT01780987
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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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ClinicalTrials.gov Identifier: NCT01780987
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 29, 2013
First Posted Date  ICMJE January 31, 2013
Results First Submitted Date  ICMJE January 20, 2016
Results First Posted Date  ICMJE June 23, 2016
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2016)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Major bleeding and Clinically Relevant Non-major bleeding [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2016)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
  • symptomatic VTE or VTE-related death [ Time Frame: 24 weeks ]
  • thrombtic burden deterioration [ Time Frame: 24 weeks ]
  • Major bleeeding [ Time Frame: 24 weeks ]
  • All bleeding [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Deep Vein Thrombosis
  • Pulmonary Embolism
Intervention  ICMJE
  • Drug: Apixaban
    10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
  • 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
Study Arms  ICMJE
  • Experimental: Apixaban
    Intervention: Drug: Apixaban
  • Active Comparator: UFH/Warfarin
    Interventions:
    • Drug: Unfractionated Heparin (UFH)
    • Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01780987
Other Study ID Numbers  ICMJE B0661024
CV185160 ( Other Identifier: BMS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2016

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