Using Clopidogrel with Atorvastatin or Rosuvastatin for Minor Stroke or TIA Patients
Official title: Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Small Vessel Stroke, a Randomized Controlled Single-blinded Trial
Run by Kafrelsheikh University · NCT06358313 · Data updated 2026-11-12
This study is testing whether adding atorvastatin or rosuvastatin to the treatment of patients who have had a minor stroke or TIA while already taking clopidogrel and aspirin can help them recover better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Kafrelsheikh University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kafr ash Shaykh) |
| Status | Recruiting |
| Started | April 10, 2024 |
| Main results expected | May 10, 2026 |
| Study ends | May 30, 2026 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT06358313 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 18-75 who have experienced a first-ever minor acute ischemic stroke or high-risk TIA.
✕Probably not a fit
Patients with more severe strokes (NIHSS ≥ 4) or those with significant comorbidities may not benefit from this study.
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 the treatment regimen of patients experiencing a first-ever minor ischemic stroke or transient ischemic attack (TIA) who are already receiving clopidogrel and aspirin. The study will randomly assign 600 patients to receive either atorvastatin or rosuvastatin for three months, with clinical outcomes assessed using the NIH Stroke Scale and Modified Rankin Scale. The trial aims to evaluate the impact of these statins on recovery and potential adverse effects within the first 24 hours of treatment.
Why it matters
Potential benefit: If successful, this study could improve recovery outcomes for patients suffering from minor strokes or TIAs.
How similar studies have gone: Other studies have shown promising results with the use of statins in stroke management, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * males and females aged 18-75 * first-ever moderate and small vessel Stroke * Patients are not eligible for rt-PA treatment Exclusion Criteria: * The investigators excluded patients who had rapidly resolving symptoms before imaging results, and patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit). * the investigators excluded patients who had clinical seizures at the onset of their stroke, as well as those who had symptoms of any major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks, and those who were on warfarin, regular ticagrelor during the week before admission, or chemotherapy within the previous year. * The investigators excluded patients with active peptic ulcers, GIT surgery, bleeding history within the last year, and those with a history of major surgery within the last three months. * The investigators ruled out of our trial patients who had a known allergy to the study drugs and those with INR \> 1.4 or P.T. \>18 or blood glucose level \< 50 or \> 400 mg/DL or blood pressure \< 90/60 or \> 185/110 mmHg on admission or Platelets \< 100,000. * The investigators excluded pregnant and lactating patients and those with stroke due to venous thrombosis and stroke following cardiac arrest or profuse hypotension ineligible for our trial. * The investigators excluded patients who were regular users of drugs that affect clopidogrel metabolism, such as ketoconazole, dihydropyridine calcium channel blockers, and rifampin.
Where it's running
-
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt Recruiting
Study contacts
- Principal investigator: mohamed G. Zeinhom, MD — neurology department kafr el-sheikh university
- Study coordinator: mohamed G. Zeinhom, MD
- Email: mohamed_gomaa@med.kfs.edu.eg
- Phone: 2001009606828
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Remote ischemic conditioning for post-stroke insomnia
A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.
-
Ear-based nerve stimulation to help sleep after a stroke
A device that delivers vagal nerve stimulation through the ear is tested to see if it helps stroke patients in rehab sleep better.
-
Theta Burst Stimulation to Help Stroke Recovery (Upper and Lower Limbs)
This trial tests whether applying theta burst stimulation to the motor cortex, in combination with standard rehabilitation, helps people over 45 who recently had a first ischemic stroke recover arm and leg movement.
-
Preventing another ischemic stroke with a smart bracelet and app
This study tests whether a digital prevention program using a wearable and a mobile app can help people who recently had an ischemic stroke reduce the chance of another stroke and improve risk-factor control.
-
Photon-counting CT to check intracranial stents
This study tests whether ultra-high-resolution photon-counting CT can reliably visualize intracranial stents and detect in-stent restenosis during follow-up of patients with prior stents.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.