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

Phase

Condition

Blood Clots

Stroke

Cerebral Ischemia

Treatment

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:

We excluded patients with allergies to any of the studied drugs or who suffered fromclinical seizures as a part of their stroke, those with major organ failure,malignancies, or myocardial infarction during the past six weeks, and patients whoadministered regular antiplatelet or anticoagulant in the previous week to avoidclouding our drug safety assessment. We excluded patients with a minor stroke (National Institutes of Health Stroke Scale (NIHSS) ≤ 3) or severe stroke (NIHSS ≥ 25), patients who had spontaneous resolution ofsymptoms before imaging, and patients with a history of a CNS disorder (e.g., multiplesclerosis, epilepsy, meningioma). Patients were also not eligible if carotid, cerebrovascular, or coronary revascularizationwas planned, requiring halting study treatment within seven days after randomization. Patients who experienced a cardioembolic stroke either prior to or post-treatment were notincluded in our study. Cardio-embolic strokes were diagnosed when the patient exhibitedpotential 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 . The patient was diagnosed with clinical AF based on the presenceof 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 andirregular RR intervals (when atrioventricular conduction is not impaired). We excluded patients with a source of gastrointestinal bleeding such as peptic ulcers,patients with recurrent stroke based on appropriate clinical history, examination, and/orMRI brain findings, and those who had a blood glucose level < 50 or > 400 mg/DL or Plateletcount < 100,000 or international normalized ratio > 1.4 or Prothrombin time >18. We excluded patients who were regular users of drugs that affected clopidogrel metabolism,such as proton pump inhibitors, ketoconazole, dihydropyridine calcium channel blockers, andrifampin. We excluded pregnant or lactating females, patients with venous infarction, and ischemicinfarction secondary to hypo-perfusion.

Study Design

Atorvastatin 40 Mg Oral Tablet

April 10, 2024

May 10, 2025

Study Description

After the ethics committee of the faculty of medicine at Kafr el-Sheik University approves, the investigators will conduct a randomized controlled trial between April 2024 and April 2025.

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
Active - Recruiting

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