Comparing Ticagrelor and Cilostazol for Ischemic Stroke Treatment
Ticagrelor Versus Cilostazol in Moderate and Moderate-to-severe Ischemic Stroke, a Randomized Controlled Trial
This study is testing whether ticagrelor works better than cilostazol for treating patients who have just had their first moderate to severe ischemic stroke.
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 | NCT06561867 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of ticagrelor versus cilostazol in patients experiencing their first moderate to severe ischemic stroke. A total of 900 patients will be randomly assigned to receive either a loading dose of ticagrelor or cilostazol within 24 hours of stroke onset, followed by a maintenance dose for 90 days. The study will assess outcomes using the NIHSS and Modified Rankin Scale, along with monitoring for adverse effects. The trial is conducted at Kafr Elsheikh University Hospital, following ethical approval and informed consent from participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 experiencing their first moderate or moderate-to-severe ischemic stroke within 24 hours of onset.
Not a fit: Patients with mild strokes (NIHSS ≤ 4) or severe strokes (NIHSS ≥ 25) 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 ischemic stroke.
How similar studies have performed: Previous studies have shown varying success with antiplatelet therapies in stroke management, making this approach both relevant and potentially impactful.
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 moderate or moderate-to-severe ischemic stroke who received antiplatelet treatment within the first 24 hours of the onset of ischemic stroke. Patients with previous transient ischemic attacks (TIA) were not excluded from the study. 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 ≤ 4 or ≥ 25 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.