nctId: NCT06358313 id: 0023098816 briefTitle: Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Minor Stroke or TIA overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-05-10 date: 2024-04-10 date: 2024-04-10 name: Kafrelsheikh University class: OTHER briefSummary: 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 minor stroke or TIA patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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 aspirin at a loading dose of 75 to 300 mg and then 75 mg daily till the end of the 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. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: 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. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Atorvastatin 40mg name: Rosuvastatin 20mg measure: the rate of new stroke at 90 days measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week measure: value of Modified Rankin Scale (mRS) at one week measure: value of Modified Rankin Scale(mRS) at three months measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events measure: rate of drug adverse effects measure: Drug adverse effects: all side effects related to the drugs of our study will be reported sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False