Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,172
- 主要终点
- Time to first symptomatic stroke for participants
研究概览
简要总结
CATIS-ICAS is a double-blind, randomized, placebo-controlled (RCT), phase III study seeking to demonstrate that oral rivaroxaban 2.5 mg twice daily plus aspirin daily is superior to clopidogrel 75 mg daily plus aspirin daily for 90 days followed by placebo plus aspirin daily for preventing recurrent stroke in those with ischemic stroke secondary to intracranial atherosclerotic disease (ICAD) of 30-99%, when started within 30 days of index stroke.
详细描述
CATIS-ICAD will recruit approximately 1172 consenting participants presenting with ischemic stroke secondary to ICAD within 30 days from symptom onset at approximately 80 high-volume stroke research centers across Canada, Europe, South America and Asia over 48 months. Participants will be randomly assigned (1:1) to oral intake of rivaroxaban 2.5 mg twice daily plus aspirin or clopidogrel 75 mg daily plus aspirin followed by aspirin plus placebo. They will be followed to a common termination date, defined as approximately 12 months following the end of recruitment (estimated mean follow-up of 36 months).
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
- 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
- •Ischemic stroke or high-risk TIA (motor and/ or speech involvement)
- •Randomization within 30 days of index stroke
- •Stroke potentially attributable to ICAS 30-99% (or flow gap on time-offlight MRA) of a major intracranial artery (internal carotid artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, intracranial vertebral artery, or basilar artery) by MRA or CTA or catheter angiography.
- •Modified Rankin Scale Score < 4 at randomization
- •Ability to obtain informed consent prior to randomization.
排除标准
- •Cardioembolic stroke
- •Indication for long-term dual antiplatelet or anticoagulant therapy (e.g. venous thromboembolism, coronary stent, mechanical prosthetic valve)
- •Intracranial arterial stenosis secondary to causes other than atherosclerosis e.g. dissection, moya moya disease
- •Substantial extracranial carotid artery disease ipsilateral to the qualifying stroke with plans for carotid revascularization
- •Intended intracranial stenting for the qualifying stroke
- •Symptomatic hemorrhagic transformation of the index stroke, or neuroradiological class 2 (PH2 type) or symptomatic class 3 on Heidelberg scale prior to randomization
- •Previous non-traumatic intracerebral hemorrhage, non-aneurysmal subarachnoid hemorrhage (treated aneurysmal subarachnoid hemorrhage will be allowed)
- •Subdural hematoma within 12 months prior to randomization or traumatic brain hemorrhage within 1 month prior to randomization
- •Advanced kidney disease at randomization (eGFR <15 ml per minute)
- •Platelet count less than 100,000/mm3 at enrolment or other bleeding diatheses
- •Uncontrolled hypertension with BP consistently above 180 mmHg for systolic and 110mmHg for diastolic while on treatment
- •Known hypersensitivity or contraindication to ASA, clopidogrel or rivaroxaban
- •Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) or P- glycoprotein (P-gp)
- •Females of childbearing potential who are not surgically sterile, pregnant, or breast-feeding
- •Previous randomization to this study
- •Participating in a study with an investigational drug or medical device that would interfere with the study at the time of randomization (participants that are no longer in an active arm of a study but are being followed may be randomized)
- •Terminal medical illness with life expectancy less than 1 year
研究组 & 干预措施
Dual pathway inhibition
rivaroxaban 2.5mg BID, plus clinical ASA
干预措施: Rivaroxaban (Drug)
Antiplatelet therapy
Placebo BID, plus clinical ASA
干预措施: ASA (Drug)
结局指标
主要结局
Time to first symptomatic stroke for participants
时间窗: From randomization until end of study visit (12 months after Last Patient First Visit)
Time to first symptomatic stroke (including ischemic, hemorrhagic and undefined) for all participants affected, by treatment arm
次要结局
未报告次要终点