Combining aspirin with cilostazol or clopidogrel for minor strokes or TIAs
Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA, a Randomized Controlled Trial
This study is testing whether combining aspirin with either clopidogrel or cilostazol can help people who have had a minor stroke or TIA feel better and recover more effectively.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 870 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT06591351 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of combining a 300 mg loading dose of clopidogrel with aspirin versus a 200 mg loading dose of cilostazol with aspirin in patients experiencing their first large-vessel minor ischemic stroke or transient ischemic attack (TIA). The study involves a single-blinded randomized controlled design with 870 participants, who will be monitored for clinical outcomes using the NIHSS and Modified Rankin Scale over a period of 90 days. Patients will undergo various assessments, including echocardiography and brain imaging, to evaluate their condition and response to treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who have experienced their first large-vessel minor ischemic stroke or TIA and can receive antiplatelet treatment within 24 hours of onset.
Not a fit: Patients with rapidly resolving symptoms, NIHSS scores below 5, or those with a history of significant CNS pathology or major organ failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from minor strokes or TIAs, potentially reducing the risk of future strokes.
How similar studies have performed: Other studies have shown promise in using dual antiplatelet therapy for stroke prevention, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with large-vessel minor ischemic stroke or TIA who received antiplatelet treatment within the first 24 hours of the onset of ischemic stroke. Patients are not eligible for rt-PA treatment Exclusion Criteria: * The investigators excluded patients who had not been followed up on for 90 days after enrollment, those with NIHSS \< 5 or 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. Patients with contraindications to the study drugs were excluded
Where this trial is running
Kafr ash Shaykh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.