COMPARISON OF ASPIRIN AND TICAGRELOR VERSUS ASPIRIN AND CLOPIDOGREL IN SECONDARY PREVENTION OF STROKE/ TRANSIENT ISCHEMIC ATTACK AMONG PATIENTS WITH ACUTE MINOR ISCHEMIC STROKE/ HIGH RISK TRANSIENT ISCHEMIC ATTACK-A RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To estimate the difference in incidence of recurrent stroke or TIA within 90 days among patients with acute minor ischemic stroke or high risk Transient ischemic attack receiving ticagrelor versus clopidogrel in addition to aspirin
研究概览
简要总结
This randomized controlled trial titled Comparison of Aspirin and Ticagrelor versus Aspirin and Clopidogrel in Secondary Prevention of Stroke or Transient Ischemic Attack among Patients with Acute Minor Ischemic Stroke High Risk Transient Ischemic Attack aims to evaluate the comparative efficacy of two dual antiplatelet regimens in preventing recurrent cerebrovascular events. Conducted at the Pondicherry Institute of Medical Sciences from July 2025 to June 2027 the study will enroll 70 patients aged 18 years or older presenting within 72 hours of a minor ischemic stroke NIHSS less than or equal to 7 or high risk TIA ABCD2 greater than or equal to 4. Participants will be randomized equally to receive either aspirin plus ticagrelor or aspirin plus clopidogrel for 21 days followed by aspirin monotherapy. The primary outcome is the incidence of recurrent stroke or TIA within 90 days while secondary outcomes include functional outcomes major adverse cardiovascular events and major bleeding. Data analysis will be performed using SPSS with statistical significance set at p less than 0.05. The study hypothesizes that aspirin plus ticagrelor will provide superior protection against recurrent ischemic events especially relevant for the Indian population with a high prevalence of CYP2C19 loss of function alleles that may reduce clopidogrel efficacy. Ethical clearance has been obtained and informed consent will be secured from all participants. The findings are expected to guide optimization of dual antiplatelet therapy for secondary stroke prevention in the Indian context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •a)Age 18 years and above both genders b)Acute minor ischemic stroke NIHSS score less than or equal to 7 c)High risk transient ischemic attack ABCD2 score greater than or equal to 4 d)Symptom onset within 72 hours.
排除标准
- •a)A known bleeding diathesis or coagulation disorder b)Patients with cardio-embolic stroke or those planned for use of anticoagulation c)Patients with history of hemorrhagic stroke or Intracranial hemorrhages in the last 3 months d) Patients with history of major surgeries in the last 30 days e) Hypersensitivity to any of the trial drugs f)Patients with thrombocytopenia less than 1 lakh g)Pregnant women & lactating mothers h)History of thrombolysis in the last 6 months for any cause i)Patients already on dual antiplatelet therapy.
结局指标
主要结局
To estimate the difference in incidence of recurrent stroke or TIA within 90 days among patients with acute minor ischemic stroke or high risk Transient ischemic attack receiving ticagrelor versus clopidogrel in addition to aspirin
时间窗: 90 days
次要结局
- a)To determine the functional outcomes in both groups using the Modified Rankin Scale (mRS)(b)To estimate the incidence of Major adverse cardiovascular events (MACE) in both groups)
研究者
SURESHKRISHNA
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES
