Combining Clopidogrel with Atorvastatin or Rosuvastatin for Ischemic Stroke Patients
Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke, a Randomized Controlled Single-blinded Trial
This study is testing whether adding atorvastatin or rosuvastatin to clopidogrel can help people who have just had their first large-vessel ischemic stroke feel better and recover more effectively.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT06360120 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of adding atorvastatin or rosuvastatin to clopidogrel treatment in patients experiencing their first large-vessel ischemic stroke. Conducted at Kafr Elsheikh University Hospital, the study will enroll 600 patients, randomly assigning them to receive either atorvastatin or rosuvastatin alongside clopidogrel. Clinical outcomes will be assessed using the NIH Stroke Scale (NIHSS) and the Modified Rankin Scale (mRS) at various intervals. The trial aims to evaluate both the efficacy and safety of these combinations within the first 24 hours of stroke onset.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-75 who are experiencing their first-ever large-vessel acute ischemic stroke.
Not a fit: Patients with severe strokes, allergies to the study drugs, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve clinical outcomes for patients suffering from large-vessel ischemic strokes.
How similar studies have performed: Previous studies have shown promising results with statin use in stroke management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- males and females aged 18-75 first-ever large-vessel acute ischemic stroke Exclusion Criteria: * the investigators excluded patients with allergies to any of the studied drugs or who suffered from clinical seizures as a part of their stroke, those with major organ failure, malignancies, or myocardial infarction during the past six weeks, and patients who administered regular antiplatelet or anticoagulant in the previous week to avoid clouding our drug safety assessment. * investigators excluded patients with a minor stroke (National Institutes of Health Stroke Scale (NIHSS) ≤ 3) or severe stroke (NIHSS ≥ 25), patients who had spontaneous resolution of symptoms before imaging, and patients with a history of a CNS disorder (e.g., multiple sclerosis, epilepsy, meningioma). * investigators excluded Patients were also not eligible if carotid, cerebrovascular, or coronary revascularization was planned, requiring halting study treatment within seven days after randomization. * investigators excluded Patients who experienced a cardioembolic stroke either prior to or post-treatment were not included in our study. Cardio-embolic strokes were diagnosed when the patient exhibited potential conditions to have a cardiac source of emboli such as mechanical cardiac valves, atrial fibrillation (AF), mitral valve prolapse, aortic valve stenosis or calcification, and patent foramen ovale . * investigators excluded patients with clinical AF based on the presence of a conventional 12-lead electrocardiography (ECG) recording that exhibited a minimum of 30 seconds of cardiac rhythm, showing the absence of identifiable recurring P waves and irregular RR intervals (when atrioventricular conduction is not impaired). * investigators excluded patients with a source of gastrointestinal bleeding such as peptic ulcers, patients with recurrent stroke based on appropriate clinical history, examination, and/or MRI brain findings, and those who had a blood glucose level \< 50 or \> 400 mg/DL or Platelet count \< 100,000 or international normalized ratio \> 1.4 or Prothrombin time \>18. * investigators excluded patients who were regular users of drugs that affected clopidogrel metabolism, such as proton pump inhibitors, ketoconazole, dihydropyridine calcium channel blockers, and rifampin. * investigators excluded pregnant or lactating females, patients with venous infarction, and ischemic infarction secondary to hypo-perfusion.
Where this trial is running
Kafr ash Shaykh
- Kafr Elsheikh University Hospital — Kafr ash Shaykh, Egypt (Recruiting)
Study contacts
- Study coordinator: mohamed G. Zeinhom, MD
- Email: mohamed_gomaa@med.kfs.edu.eg
- Phone: 2001009606828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.