NCT06360120 Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke
| NCT ID | NCT06360120 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kafrelsheikh University |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2025-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2024-04-10 with a primary completion date of 2025-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
mohamed G. Zeinhom, MD
STUDY DIRECTOR
neurology department kafr el-sheikh university
Frequently Asked Questions
Who can join the NCT06360120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06360120 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT06360120 currently recruiting?
Yes, NCT06360120 is actively recruiting participants. Contact the research team at mohamed_gomaa@med.kfs.edu.eg for enrollment information.
Where is the NCT06360120 trial being conducted?
This trial is being conducted at Kafr ash Shaykh, Egypt.
Who is sponsoring the NCT06360120 clinical trial?
NCT06360120 is sponsored by Kafrelsheikh University. The principal investigator is mohamed G. Zeinhom, MD at neurology department kafr el-sheikh university. The trial plans to enroll 600 participants.
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