Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Moderate and Moderate-to-severe Stroke, a Randomized Controlled Single-blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- the rate of new stroke at 90 days
研究概览
简要总结
Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever moderate and moderate to severe stroke patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects.
详细描述
The investigators will conduct a randomized controlled trial between April 2024 and April 2025 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approves.
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 atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months.
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
Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients 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 atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician.
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
- •males and females aged 18-75
- •first-ever moderate and Moderate-to-severe Ischemic Stroke
- •Patients are not eligible for rt-PA treatment
排除标准
- •The investigators excluded patients 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 of 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.
- •The investigators excluded patients who were regular users of drugs that affect clopidogrel metabolism, such as ketoconazole, dihydropyridine calcium channel blockers, and rifampin.
研究组 & 干预措施
atorvastatin
The Atorvastatin arm consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, an open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months
干预措施: Atorvastatin 40mg (Drug)
rosuvastatin
The rosuvastatin arm consisted of 300 patients who received 20 mg daily rosuvastatin for 3 months and an open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months
干预措施: Rosuvastatin 20mg (Drug)
结局指标
主要结局
the rate of new stroke at 90 days
时间窗: 90 days
Rates of new ischemic 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 recurrence of ischemic stroke.
次要结局
- Value of National Institute of Health Stroke Scale (NIHSS) after one week(7 days)
- rate of drug adverse effects(90 days)
- value of Modified Rankin Scale(mRS) at three months(3 months)
- value of Modified Rankin Scale (mRS) at one week(7 days)
- rate of composite recurrent stroke, myocardial infarction, and death due to vascular events(3 months)
- Drug adverse effects: all side effects related to the drugs of our study will be reported(90 days)
研究者
Mohamed G. zeinhom, MD
principal investigator
Kafrelsheikh University