protocolSection identificationModule nctId: NCT06360120, orgStudyIdInfo id: 00023098816, briefTitle: Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-04-10, completionDateStruct date: 2025-05-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule 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 large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects., conditionsModule conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo 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 clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months, primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Atorvastatin 40 Mg Oral Tablet, interventions name: Rosuvastatin 20mg, outcomesModule primaryOutcomes measure: the rate of new stroke at 90 days, secondaryOutcomes measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week, secondaryOutcomes measure: value of Modified Rankin Scale (mRS) at one week, secondaryOutcomes measure: value of Modified Rankin Scale(mRS) at three months, secondaryOutcomes measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events, secondaryOutcomes measure: rate of drug adverse effects, secondaryOutcomes measure: Drug adverse effects: all side effects related to the drugs of our study will be reported, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kafr Elsheikh University Hospital, status: RECRUITING, city: Kafr Ash Shaykh, zip: 33511, country: Egypt, contacts name: mohamed G. Zeinhom, MD, role: CONTACT, phone: 2001009606828, email: mohamed_gomaa@med.kfs.edu.eg, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False