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

Phase

Condition

Stroke

Blood Clots

Cerebral Ischemia

Treatment

Clopidogrel 75 Mg Oral Tablet

Atorvastatin 40 Mg Oral Tablet

Rosuvastatin 20mg

Clinical Study ID

NCT06360120

00023098816

Ages 18-75
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

the investigators excluded patients with allergies to any of the studied drugs orwho suffered from clinical seizures as a part of their stroke, those with majororgan failure, malignancies, or myocardial infarction during the past six weeks, andpatients who administered regular antiplatelet or anticoagulant in the previous weekto avoid clouding our drug safety assessment.
investigators excluded patients with a minor stroke (National Institutes of HealthStroke Scale (NIHSS) ≤ 3) or severe stroke (NIHSS ≥ 25), patients who hadspontaneous resolution of symptoms before imaging, and patients with a history of aCNS 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 withinseven days after randomization.
investigators excluded Patients who experienced a cardioembolic stroke either priorto or post-treatment were not included in our study. Cardio-embolic strokes werediagnosed when the patient exhibited potential conditions to have a cardiac sourceof emboli such as mechanical cardiac valves, atrial fibrillation (AF), mitral valveprolapse, aortic valve stenosis or calcification, and patent foramen ovale .
investigators excluded patients with clinical AF based on the presence of aconventional 12-lead electrocardiography (ECG) recording that exhibited a minimum of 30 seconds of cardiac rhythm, showing the absence of identifiable recurring P wavesand irregular RR intervals (when atrioventricular conduction is not impaired).
investigators excluded patients with a source of gastrointestinal bleeding such aspeptic ulcers, patients with recurrent stroke based on appropriate clinical history,examination, and/or MRI brain findings, and those who had a blood glucose level < 50or > 400 mg/DL or Platelet count < 100,000 or international normalized ratio > 1.4or Prothrombin time >18.
investigators excluded patients who were regular users of drugs that affectedclopidogrel metabolism, such as proton pump inhibitors, ketoconazole,dihydropyridine calcium channel blockers, and rifampin.
investigators excluded pregnant or lactating females, patients with venousinfarction, and ischemic infarction secondary to hypo-perfusion.

Study Design

Clopidogrel 75 Mg Oral Tablet

April 10, 2024

October 01, 2025

Study Description

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.

Every patient underwent CT brain and MRI brain using stroke protocol: T1W, T2W, FLAIR, DWI, T2 Echo Gradient, CTA, or MRA (if CTA was contraindicated), from the aortic arch through the circle of Willis. Two neuroradiologists blinded to treatment reviewed C.T. and MRI source images. Cerebrovascular vessels were divided into segments: supra-clinoid internal carotid artery, first-division middle cerebral artery (M1), second-division middle cerebral artery (M2), basilar artery (B.A.), intracranial vertebral artery (V.A.). A neuroradiologist determined whether any of these vascular segments were occluded. If there was no vascular occlusion, the patient was documented as having no large vessel occlusion. If one or more vascular segments were occluded and the patient was ineligible for thrombectomy or arterial stenting, the case history and NIHSS score were reviewed; if the vascular occlusion was in the appropriate territory to account for the clinical findings, the case was judged as having a large-vessel occlusion

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.

Connect with a study center

Kafr Elsheikh University Hospital
Kafr Ash Shaykh, 33511
Egypt
Site Not Available
Kafr Elsheikh University Hospital
Kafr ash Shaykh 354502, 33511
Egypt
Active - Recruiting

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