NCT06358313

Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Moderate and Moderate-to-severe Stroke

Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Moderate and Moderate-to-severe Stroke, a Randomized Controlled Single-blinded Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: Clinical workup: History, clinical assessment \& NIHSS were recorded on admission, day 7, and the Modified Rankin Scale as a follow-up after one week and 3 months. Detection of Risk Factors \& Profiles: Echocardiography\& TOE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. - Carotid Duplex: carotid duplex in indicated patients. 4- ESR \& Lipid Profile\& liver functions: All will be tested routinely for all patients. Imaging Follow-UP Non-contrast CT brain on admission Day 2 MRI: After 2 days of admission, all the patients in this study will have a brain MRI (stroke protocol; T1W, T2W, FLAIR, DWI, T2 Echo Gradient, MRA of all intra-cerebral vessels). CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT. Primary End Point: The primary efficacy outcome was the rate of new stroke at 90 days • Secondary End Point: the secondary efficacy outcomes were to evaluate the rates of patients who achieved a significant reduction in NIHSS (decrease of four points or more) at the seventh day or discharge compared to baseline, the rates of a favorable outcome with (mRS = 0-2) after one week and after 90 days in a face-to-face interview in the outpatient clinic, rates of the composite of recurrent stroke, myocardial infarction, and death due to vascular events after 90 days of follow-up, while the secondary safety outcome was the rate of treatment-related acute liver injury assessed by ALT, AST test at 90 days, statin-induced myopathy assessed by CPK at 90 days and other adverse effects assessed by a follow-up questionnaire.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Atorvastatin 40mg	The atorvastatin group consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months.
DRUG	Rosuvastatin 20mg	The rosuvastatin group consisted of 300 patients who received 40 mg daily rosuvastatin for 3 months, and open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months.

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-12-10
• Completion: 2025-12-30
• First posted: 2024-04-10
• Last updated: 2025-09-05

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study