Using Clopidogrel with Atorvastatin or Rosuvastatin for Minor Stroke or TIA Patients

Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Small Vessel Stroke, a Randomized Controlled Single-blinded Trial

This study is testing whether adding atorvastatin or rosuvastatin to the treatment of patients who have had a minor stroke or TIA while already taking clopidogrel and aspirin can help them recover better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kafrelsheikh University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Kafr ash Shaykh)
• Trial ID: NCT06358313 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of adding atorvastatin or rosuvastatin to the treatment regimen of patients experiencing a first-ever minor ischemic stroke or transient ischemic attack (TIA) who are already receiving clopidogrel and aspirin. The study will randomly assign 600 patients to receive either atorvastatin or rosuvastatin for three months, with clinical outcomes assessed using the NIH Stroke Scale and Modified Rankin Scale. The trial aims to evaluate the impact of these statins on recovery and potential adverse effects within the first 24 hours of treatment.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18-75 who have experienced a first-ever minor acute ischemic stroke or high-risk TIA.

Not a fit: Patients with more severe strokes (NIHSS ≥ 4) or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve recovery outcomes for patients suffering from minor strokes or TIAs.

How similar studies have performed: Other studies have shown promising results with the use of statins in stroke management, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* males and females aged 18-75
* first-ever moderate and small vessel Stroke
* Patients are not eligible for rt-PA treatment

Exclusion Criteria:

* 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 \< 100,000.
* 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.

Where this trial is running

Kafr ash Shaykh

• Kafr Elsheikh University Hospital — Kafr ash Shaykh, Egypt (Recruiting)

Study contacts

• Principal investigator: mohamed G. Zeinhom, MD — neurology department kafr el-sheikh university
• Study coordinator: mohamed G. Zeinhom, MD

Conditions Ischemic Stroke; atorvastatin; rosuvastatin; clopidogrel; stroke; Egypt