Combining aspirin with ticagrelor or clopidogrel for minor strokes or TIAs
Combining Aspirin With Ticagrelor or Clopidogrel in Large-vessel Minor Stroke or TIA, a Randomized Controlled Trial
This study is testing whether a higher dose of ticagrelor works better than clopidogrel for people who have had a minor stroke or a transient ischemic attack.
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 | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT06591338 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 300 mg loading dose of clopidogrel in patients experiencing their first-ever large-vessel minor ischemic stroke or transient ischemic attack (TIA). Conducted as a single-blinded randomized controlled trial, it involves 900 patients who will be monitored for clinical outcomes and potential adverse effects over a 90-day period. Participants will undergo various assessments, including clinical evaluations, imaging studies, and risk factor profiling, to determine the best antiplatelet therapy for this patient population.
Who should consider this trial
Good fit: Ideal candidates 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 NIHSS scores below 5, rapidly resolving symptoms, or a history of significant CNS pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective antiplatelet treatment option for patients suffering from minor strokes or TIAs.
How similar studies have performed: Other studies have shown promising results with similar antiplatelet approaches, suggesting potential for success in this trial.
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
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.