A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome

BristolMyers Squibb37 个研究点分布在 1 个国家目标入组 1,080 人开始时间: 待定

适应症

试验速览

阶段: 3 期
发起方
入组人数: 1,080
试验地点: 37
主要终点: Primary Outcome Measures: Time to first occurrence of cardiovascular death, myocardial infarction, or ischemic stroke [ Time Frame: At the time of first event ] [ Designated as safety issue: No ]

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndromehe trial is part of a global trial and where currently recruitment is underway, It is estimated that total of 1080 patients will be recruited from Indian sites. The recruitment in India has started and as on date we have a total of 16 patients enrolled for the study.

研究设计

盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

入选标准

•Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No CriteriaInclusion Criteria:Acute coronary syndrome (ACS) Clinically stable Receiving standard of care for ACS.

排除标准

•Exclusion Criteria:Severe hypertension Active bleeding or high risk for major bleeding Hemoglobin less than 9 g/dL.

结局指标

主要结局

Primary Outcome Measures: Time to first occurrence of cardiovascular death, myocardial infarction, or ischemic stroke [ Time Frame: At the time of first event ] [ Designated as safety issue: No ]

次要结局

Secondary Outcome Measures: Unstable angina [ Time Frame: At the time of first event ] [ Designated as safety issue: No ]Hemorrhagic stroke [ Time Frame: At the time of first event ] [ Designated as safety issue: Yes ]Fatal bleeding [ Time Frame: At the time of first event ] [ Designated as safety issue: Yes ]

研究者

发起方

BristolMyers Squibb

申办方类型

Pharmaceutical industry-Global

研究点 (37)

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