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Completed

NCT Number: NCT00787150

A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 20 years outpatient (regardless of sex)
  • Patients diagnosed as non-valvular atrial fibrillation (NVAF)
  • One or more following risks of stroke.

Exclusion criteria

  • Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
  • Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
  • Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.

Treatment and study plan

Apixaban

Drug

Apixaban 5 mg tablet BID for 12 weeks

Warfarin sodium

Drug

At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks

Primary outcomes

  1. Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period

    Time frame: Baseline to Week 12

    Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.

Secondary outcomes

  1. Number of Participants With Total Bleeding Events During the Treatment Period

    Time frame: Baseline to Week 12

    Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.

  2. Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period

    Time frame: Baseline to Week 12

    Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.

  3. Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period

    Time frame: Baseline to Week 12

    Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.

  4. Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period

    Time frame: Baseline to Week 12

    The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.

  5. Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period

    Time frame: Baseline to Week 12

    The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.

  6. Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period

    Time frame: Baseline to Week 12

    The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.

Other outcomes

  1. Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban

    Time frame: 0, 2, 4 hours postdose at Week 1 and Week 8

    Sample at 4 hours postdose was to be taken if possible.

  2. Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban

    Time frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

    Sample at 4 hours postdose was to be taken if possible.

  3. Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban

    Time frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

    Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.

  4. Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban

    Time frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

    Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.

  5. Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban

    Time frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

    Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.

  6. Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban

    Time frame: Week 0, Week 1, Week 8

    Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.

  7. Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban

    Time frame: Week 0, Week 1, Week 8

    Below the limit of quantification (BLQ) was assigned the value 0 for calculation.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 7, 2008
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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