Combining Aspirin With Ticagrelor or Clopidogrel in Minor Stroke or TIA, a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- rate of new stroke
研究概览
简要总结
Along with the current clinical trial, the efficacy and safety of a 180 mg loading dose of ticagrelor administered within 24 hours of the first-ever minor stroke or TIA compared to 300 mg clopidogrel were assessed through NIHSS, mRS, and possible adverse effects.
详细描述
The investigators conducted a single-blinded randomized controlled trial after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it.
The investigators got written informed consent from all eligible patients or their first order of kin before randomization.
The study will be composed of 2 arms ticagrelor arm, which consisted of 450 patients who received a 180mg loading dose followed by 90 mg twice daily from the 2nd to the 90th day), and the clopidogrel arm, consisting of 450 patients who received (a 300mg loading dose during the first 24 hours of stroke onset followed by 75mg once daily from the 2nd day to the 90th day),
Study Procedures:
Every patient in our study will undergo:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
An independent statistician generated a blocked randomization sequence using computer-generated random numbers; in a one-to-one ratio, participants were randomly assigned to receive loading doses of clopidogrel and aspirin or ticagrelor and aspirin by a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 900 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 900. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened, and the patients were assigned to receive drugs A or B. Drug A included ticagrelor, and Drug B included clopidogrel. Both groups received an open-label loading dose of 300 mg of aspirin and continued on aspirin 75 mg daily.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with minor ischemic stroke or TIA who received antiplatelet treatment within the first 24 hours of the onset of ischemic stroke. Patients are not eligible for rt-PA treatment
排除标准
- •The investigators excluded patients who had not been followed up on for 90 days after enrollment, those with NIHSS < 5 or who had rapidly resolving symptoms before imaging results, and patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit).
- •The investigators excluded patients who had clinical seizures at the onset of their stroke, as well as those who had symptoms of any major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks, and those who were on warfarin, regular ticagrelor during the week before admission, or chemotherapy within the previous year.
- •The investigators excluded patients with active peptic ulcers, GIT surgery, bleeding history within the last year, and those with a history of major surgery within the last three months.
- •The investigators ruled out our trial patients who had a known allergy to the study drugs and those with INR > 1.4 or P.T. >18 or blood glucose level < 50 or > 400 mg/DL or blood pressure < 90/60 or > 185/110 mmHg on admission or Platelets < 100,
- •The investigators excluded pregnant and lactating patients and those with stroke due to venous thrombosis and stroke following cardiac arrest or profuse hypotension ineligible for our trial.
- •Patients with contraindications to the study drugs were excluded.
研究组 & 干预措施
Ticagrelor and aspirin arm
The ticagrelor arm will receive (a 180 mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 90 mg twice daily from the 2nd day to the 90th day) and an open-label loading 300 mg aspirin, followed by a maintenance dose of 75 mg aspirin.
干预措施: Ticagrelor 90 MG (Drug)
clopidogrel and aspirin arm
The clopidogrel arm will receive (a 300 mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 75 mg once daily from the 2nd day to the 90th day) and open-label loading 300 mg aspirin, followed by a maintenance dose of 75 mg aspirin.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
rate of new stroke
时间窗: 90 days
Rates of new stroke occur within three months of treatment. The investigators will perform follow-ups of the patient during visits to the outpatient clinic, and brain CT and/ or MRI will be done if there is suspicion of a new stroke.
Rate of drug-related hemorrhagic complications
时间窗: 90 days
the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin \> 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites.
次要结局
- value of Modified Rankin Scale(mRS) at three months(3 months)
- rate of composite recurrent stroke, myocardial infarction, and death due to vascular events(3 months)
- rate of drug adverse effects(3 months)
研究者
Mohamed G. zeinhom, MD
principal investigator
Kafrelsheikh University