Combining aspirin with cilostazol or clopidogrel for minor stroke or TIA treatment
Combining Aspirin With Cilostazol or Clopidogrel in Minor Stroke or TIA, a Randomized Controlled Trial
This study is testing whether taking aspirin with either cilostazol or clopidogrel can help people who have had a minor stroke or TIA recover better and stay safe.
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 | NCT06591299 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of combining aspirin with either cilostazol or clopidogrel in patients experiencing a minor stroke or transient ischemic attack (TIA). It involves a single-blinded randomized controlled design with two arms: one group receiving clopidogrel and the other receiving cilostazol, both monitored for clinical outcomes and adverse effects. Patients undergo a thorough clinical assessment, including NIHSS and Modified Rankin Scale evaluations, alongside imaging studies to track their progress over 90 days. The study is conducted at Kafr Elsheikh University Hospital in Egypt.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have experienced their first-ever minor ischemic stroke or TIA and can receive antiplatelet treatment within 24 hours.
Not a fit: Patients with rapidly resolving symptoms, known CNS pathologies, or those on certain anticoagulant therapies 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 improving recovery outcomes.
How similar studies have performed: Other studies have shown promise in using antiplatelet combinations for stroke treatment, but this specific approach is being evaluated for the first time.
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 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.