Combining Aspirin with Ticagrelor or Cilostazol for Minor Stroke Treatment
Combining Aspirin With Ticagrelor or Cilostazol in Large-vessel Minor Stroke or TIA, a Randomized Controlled Trial
This study is testing whether taking ticagrelor or cilostazol can help people who have had a minor stroke or TIA avoid more strokes and feel better over the next 90 days.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06591377 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a 180 mg loading dose of ticagrelor compared to a 200 mg loading dose of cilostazol in patients experiencing their first-ever large-vessel minor stroke or transient ischemic attack (TIA). The study involves a single-blinded randomized controlled design with 450 patients in each treatment arm. Participants will undergo clinical assessments, including NIHSS and Modified Rankin Scale evaluations, along with imaging studies to monitor their condition over a 90-day period. The trial aims to determine which antiplatelet therapy is more effective in preventing further strokes and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who have experienced their first-ever 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 subsequent strokes.
How similar studies have performed: Other studies have shown promising results with similar antiplatelet therapies, suggesting that this approach may be effective, although this specific combination is being tested 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 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 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
Cairo and 1 other locations
- El-sahel teaching hospital — Cairo, Egypt (Recruiting)
- 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.