Comparing Ticagrelor and Cilostazol for Large-vessel Ischemic Stroke

Ticagrelor Versus Cilostazol in Ischemic Stroke

This study is testing whether ticagrelor or cilostazol is better at helping people who have had their first large-vessel ischemic stroke recover and stay healthy over the next 90 days.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (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: NCT06202755 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of ticagrelor versus cilostazol in patients experiencing their first large-vessel ischemic stroke. Participants 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 NIH Stroke Scale (NIHSS) and the Modified Rankin Scale (mRS) at various time points. The trial is single-blinded and will take place at Kafr Elsheikh University Hospital from March 2024 to June 2025.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 experiencing their first large-vessel ischemic stroke within 24 hours of onset.

Not a fit: Patients with mild strokes (NIHSS ≤ 3) 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 large-vessel ischemic strokes.

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

Inclusion Criteria:

* the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with acute large-vessel 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:

* he investigators excluded patients who had not been followed up on for 90 days after enrollment, those with NIHSS ≤ 3 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.

Where this trial is running

Kafr ash Shaykh

• Kafr Elsheikh University Hospital — Kafr ash Shaykh, Egypt (Recruiting)

Study contacts

• Study coordinator: mohamed G Zeinhom, MD

Conditions Ischemic Stroke; ticagrelor; large-vessel ischemic stroke; cilostazol