Combination Anti-thrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease: Protocol for a Pilot Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Recruitment rate
研究概览
简要总结
CATIS-ICAD is a clinical pilot study in which patients who have had a recent ischemic stroke, that is a stroke caused by a blood clot or a narrowing of the blood vessels in the brain due to the build up of plaque, will be randomly assigned to receive either low-dose rivaroxaban + aspirin or aspirin alone.
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
- Single (Outcomes Assessor)
盲法说明
Blinded assessment of endpoint
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
- •Recent brain ischemia attributed to intracranial atherosclerotic stenosis of 30-99% as evidenced by CT or MR angiography, occurring between 7 to 100 days prior to randomization and consisting of either:
- •a high-risk TIA defined as TIA with motor and/or speech involvement or
- •an ischemic stroke
- •Written informed consent consistent with local regulations governing research in human subjects
排除标准
- •Indication for DAPT for > 90 days on guideline recommendations or investigator ́s judgment; e.g., cardiac stenting.
- •Indication for chronic anticoagulation based on guideline recommendations or investigator ́s judgment; e.g. patient with prosthetic mechanical valve, venous thromboembolism, hypercoagulable state
- •Atrial fibrillation or a history of atrial fibrillation
- •Intracranial arterial occlusion (e.g. 100% stenosis) responsible for the acute brain ischemia
- •Intracranial arterial stenosis secondary to causes other than atherosclerosis
- •Extracranial carotid artery disease ipsilateral to the qualifying brain ischemia with a plan for carotid revascularization
- •Intraluminal thrombus
- •Subdural hematoma within 12 months of randomization
- •Previous spontaneous hemorrhagic stroke (e.g. intracerebral or subarachnoid hemorrhage)
- •Traumatic brain hemorrhage within 1 month of randomization
- •Contraindication for MRI scan (e.g. pacemaker incompatible with MRI)
- •Advanced kidney disease (recent estimated GFR <30 ml per minute)
- •Modified Rankin Scale (mRS) >=4 at entry
- •Platelet count less than 100,000/mm3 at enrolment or other bleeding diathesis
- •Uncontrollable hypertension with systolic BP/ diastolic BP consistently above180/100mmHg after treatment
- •Known hypersensitivity to either ASA or rivaroxaban
- •Life expectancy less than 6 months
- •Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e., human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, or posaconazole, if used systemically
- •Female of childbearing potential who are not surgically sterile, or, if sexually active not willing to use adequate contraceptive measures with a failure rate less than 1% per year (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study, as well as pregnant or breast-feeding women
- •Inability to adhere to study procedures
- •Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
- •Previous randomization to this study or participating in a study with an investigational drug or medical device at the time of randomization
- •Antiphospholipid antibody syndrome
研究组 & 干预措施
Experimental (riva + ASA)
Rivaroxaban 2.5mg bid + aspirin 81mg qd
干预措施: Rivaroxaban 2.5 Mg Oral Tablet bid (Drug)
Experimental (riva + ASA)
Rivaroxaban 2.5mg bid + aspirin 81mg qd
干预措施: Acetylsalicyclic acid 81 mg tablet qd (Drug)
Control (ASA alone)
Aspirin 81 mg qd
干预措施: Acetylsalicyclic acid 81 mg tablet qd (Drug)
结局指标
主要结局
Recruitment rate
时间窗: From randomization to end of recruitment (2 years)
Recruitment rate of potentially eligible patients from neurology clinics
Refusal rate
时间窗: From randomization to end of recruitment (2 years)
Rate of patients who refuse to participate in the clinical trial who otherwise are eligible for the study
Retention rate
时间窗: From randomization to End of Study (median 2 years)
Rate of patients who remain in the clinical trial until EOS or qualifying event
Incidence rate of Intracranial hemorrhage
时间窗: From randomization to End of Study (median 2 years)
Rate of patients who experience an intracranial hemorrhage during the study
次要结局
- Recurrent ischemic stroke(From randomization to End of Study (median 2 years))
- Composite of stroke, myocardial infarction or vascular death(From randomization to End of Study (median 2 years))
- Major hemorrhage(From randomization to End of Study (median 2 years))
- Combination of ISTH major hemorrhages & clinically-relevant non-major hemorrhages(From randomization to End of Study (median 2 years))
- Recurrent ischemic stroke & MRI-detected incident covert brain infarction(From randomization to End of Study (median 2 years))