A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS- 986141 For the Prevention of Recurrent Brain Infarction in Subjects Receiving Acetylsalicylic Acid (ASA) Following Acute Ischemic Stroke or Transient Ischemic Attack
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 23
- 主要终点
- Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
研究概览
简要总结
The purpose of this study is to determine whether BMS-986141 is effective in reducing the recurrence of stroke in people who recently had a stroke, or a transient ischemic attack (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as aspirin or ASA) to treat the stroke or TIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 or older
- •Must have had a very recent stroke or transient ischemic attack ("mini stroke") that can be confirmed by the study doctor
- •Able to be assigned to a study group no later than 48 hours after the stroke occurred
- •Has an image of the brain that confirms that the stroke was not caused by hemorrhage or other reason that could explain symptoms
排除标准
- •A suspicion by the study doctor that the transient ischemic attack or stroke was caused by a blood clot that formed in the heart; examples of this include history of an abnormal heart rhythm known as atrial fibrillation or a ventricular aneurysm or defect of the heart.
- •Any condition requiring treatment with an anticoagulant
- •History of intracranial hemorrhage ("bleeding in the brain")
- •Gastrointestinal ("stomach or intestinal") bleeding in the last 3 months that required treatment
- •Planned or anticipated invasive surgery or procedure during the study
- •Unable to tolerate MRI procedures.
研究组 & 干预措施
BMS-986141 0.8mg
BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
干预措施: BMS-986141 (Drug)
BMS-986141 0.8mg
BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
干预措施: Aspirin (Drug)
BMS-986141 4.8mg
BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
干预措施: BMS-986141 (Drug)
BMS-986141 4.8mg
BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
干预措施: Aspirin (Drug)
Placebo
Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
干预措施: Aspirin (Drug)
Placebo
Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
时间窗: 28 Days
The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.
Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period
时间窗: Up to 90 days
The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.
次要结局
- Percentage of Participants With Major Adverse Cardiovascular Events (MACE)(90 days)
- Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)(Day 28)
- Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90(Day 90)
- Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death(Day 90)