RecruitingPhase 3NCT06360120

Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke

Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke, a Randomized Controlled Single-blinded Trial


Sponsor

Kafrelsheikh University

Enrollment

600 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

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 large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • \- males and females aged 18-75 first-ever large-vessel acute ischemic stroke

Exclusion Criteria8

  • 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.

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Interventions

DRUGAtorvastatin 40 Mg Oral Tablet

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.

DRUGRosuvastatin 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.

DRUGClopidogrel 75 Mg Oral Tablet

open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months.

DRUGClopidogrel 75 Mg Oral Tablet

open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months.


Locations(1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt

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NCT06360120


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