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

Pfizer222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

222

Conditions

Atrial Fibrillation

Interventions

ApixabanDRUG

Apixaban 5 mg tablet BID for 12 weeks

ApixabanDRUG

Apixaban 2.5 mg tablet BID for 12 weeks

Warfarin sodiumDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (18)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Pfizer Investigational Site

Seto, Aichi-ken, Japan

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline to Week 12

Secondary Outcomes

Number of Participants With Total Bleeding Events During the Treatment Period

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.

Time frame: Baseline to Week 12

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

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.

Time frame: Baseline to Week 12

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

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.

Data from ClinicalTrials.gov

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