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

Phase 2

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Apixaban
Drug: Warfarin sodium

Registration Number: NCT00787150

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 222

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apixaban 5mg BID	Apixaban	-
Apixaban 2.5mg BID	Apixaban	-
Warfarin	Warfarin sodium	-

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Number of Participants With Total Bleeding Events During the Treatment Period	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.
Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period	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.
Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period	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.
Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period	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.
Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period	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.
Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period	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.