Combining Clopidogrel with Atorvastatin or Rosuvastatin for Ischemic Stroke Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.