NCT01994720已完成3 期
A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events With Ticagrelor Compared to Aspirin (ASA) in Patients With Acute Ischaemic Stroke or TIA.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 13,307
- 试验地点
- 1
- 主要终点
- Number of Participants With Composite of Stroke/MI/Death
研究概览
简要总结
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women equal or elder 40 years of age
- •Either acute ischaemic stroke or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms
排除标准
- •Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins). - Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke. - Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation. - Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation - History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days.
研究组 & 干预措施
ticagrelor
Experimental
干预措施: ticagrelor (Drug)
Acetylsalicylic acid (ASA)
Active Comparator
干预措施: Acetylsalicylic acid (ASA) (Drug)
结局指标
主要结局
Number of Participants With Composite of Stroke/MI/Death
时间窗: From randomization up to 97 days
Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
次要结局
- Number of Participants With All-Cause Death(From randomization up to 97 days)
- Net Clinical Outcome(From randomization up to 97 days)
- Number of Participants With Composite of Ischaemic Stroke, MI and CV Death(From randomization up to 97 days)
- Number of Participants With Fatal Stroke(From randomization up to 97 days)
- Number of Participants With Disabling Stroke(From randomization up to 97 days)
- EQ-5D at Visit 1 (Enrolment)(Visit 1 (Enrolment))
- Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event(Time from first dose and up to and including 7 days following the date of last dose of the study)
- Number of Participants With Ischaemic Stroke(From randomization up to 97 days)
- Number of Participants by Severity of Stroke and Overall Disability(From randomization up to 97 days)
- Number of Participants With Stroke(From randomization up to 97 days)
- Change in NIHSS(From randomization up to 97 days)
- EQ-5D at Visit 2 (Day 7+-2d)(Visit 2 (Day 7+-2d))
- Number of Participants With PLATO Major Bleeding Event(From randomization up to 97 days)
- Number of Participants With CV Death(From randomization up to 97 days)
- Number of Participants With MI(From randomization up to 97 days)
- EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit(End of treatment visit (Day 90+-7d))
- EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit(Premature treatment discontinuation visit(<15 days after last dose))
研究者
研究点 (1)
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