A Phase 2, Randomised, Double-blind, Positive-controlled, Multicentre Study of Tiprogrel in the Treatment of Patients with Acute Minor Ischaemic Stroke or High-risk Transient Ischaemic Attack.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Percent of participants with ischemic stroke
研究概览
简要总结
This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.
详细描述
To evaluate the safety and efficacy of Tiprogrel at different doses within 24 hours after symptom onset in Patients with Acute Minor Ischaemic Stroke or High-risk Transient Ischaemic Attack. Patients wil be enrolled and randomized to Low-dose Tiprogrel, High-dose Tiprogrel and Clopidogrel group in a 1:1:1 ratio.
Patients in Low-dose Tiprogrel group and High-dose Tiprogrel group will accept long term dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 90 days) . Patients in Clopidogrel group will accept dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 21 days followed by Clopidogrel on days 22 to 90) .
The primary endpoint is Percent of participants with ischemic stroke on the 90th day after treatment.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Acute Minor Ischaemic Stroke：AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, NIHSS ≤5, and either of the following imaging characteristics:
- •Acute single infarction with ≥50% stenosis of a major intracranial or extracranial artery.
- •Acute multiple infarctions attributed to large-artery atherosclerosis, including non-stenotic vulnerable plaques.
- •TIA with high risk of stroke: ABCD2 score ≥ 6 at the time of randomization, and the following imaging characteristic:
- •a）TIA with ≥50% stenosis of a major intracranial or extracranial artery. 3）Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle) 4）A man or woman of childbearing potential does not have any plan to have a child from signing the informed consent to 3 months after the last dose 5）Written informed consent Exclusion Criteria
- •Bleeding or other pathological brain disorders including malformation, tumor, abscess or other major non-ischemic brain disease on baseline head CT or MRI
- •Isolated or pure sensory symptoms, isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
- •Preceding mRS> 2
- •Contraindication to anti-platelet therapy
- •Clear indication for anticoagulation
- •Two or more antiplatelet drugs have been used continuously for ≥3 days before enrollment.
- •Used heparin or oral anticoagulant drugs within 10 days before enrollment
- •Undergone intravenous or arterial thrombolysis and mechanical thrombectomy within 24 hours before enrollment
- •History of intracranial hemorrhage or amyloid angiopathy
- •History of aneurysm
- •Diagnosis or suspicious diagnosis of acute coronary syndrome
- •History of asthma
- •High-risk for bradyarrhythmia
- •Anticipated requirement for long-term (>5 days) non-steroidal anti-inflammatory drugs or NSAIDs within the 8th day of randomization
- •History of gastrointestinal bleeding within 3 months before enrollment or major surgery within 30 days
- •Iatrogenic causes of minor stroke or TIA
- •Planned or likely revascularization within the next 3 months, scheduled for surgery or interventional treatment requiring study drug cessation
- •Severe non-cardiovascular comorbidity with life expectancy < 3 months
- •Women of childbearing age who have not taken effective contraceptive measures and have a positive pregnancy test record, as well as women who are pregnant or breastfeeding
- •Currently receiving an experimental drug or device
- •Participation in another clinical study with an experimental product during the last 30 days
- •Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
- •Hemoglobin <90g/L %
- •Permanent hypertension
- •Subjects who were judged by the investigator to be unsuitable for this clinical study
排除标准
- 未提供
研究组 & 干预措施
Low-dose Tiprogrel group
Drug: Tiprogrel and Aspirin Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
干预措施: Tiprogrel (Drug)
High-dose Tiprogrel group
Drug: Tiprogrel and Aspirin Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
干预措施: Tiprogrel (Drug)
Clopidogrel group
Drug: Clopidogrel and Aspirin Day 1, loading dose of Clopidogrel and loading dose of aspirin; Day 2-21, daily maintenance dose of Clopidogrel and daily maintenance dose of aspirin; D22-90: daily maintenance dose of Clopidogrel.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Percent of participants with ischemic stroke
时间窗: on the 90th day after treatment
Participants with ischemic stroke
次要结局
- Percent of participants with ischemic Stroke(on the 21th day after treatment)
- Percent of participants with serve composite ischemic events: nonfatal ischemic strokes, nonfatal myocardial infarction or death from ischemic vascular causes(on the 21th and 90th day after treatment)
- Percent of participants with nonfatal ischemic strokes(on the 21th and 90th day after treatment)
- Percent of participants with nonfatal myocardial infarction(on the 21th and 90th day after treatment)
- Percent of participants with death from ischemic vascular events(on the 21th and 90th day after treatment)
- Percent of participants with ischemic vascular events(on the 21th and 90th day after treatment)
- Percent of participants with stroke (ischemic or hemorrhagic)(on the 21th and 90th day after treatment)
- Percent of participants with cardiovascular death(on the 21th and 90th day after treatment)
- Scores on the modified Rankin scale range(on the 90th day after treatment)