NCT06196047

Ticagrelor Versus Cilostazol in Minor Ischemic Stroke or TIA

Ticagrelor Versus Cilostazol in Ischemic Stroke

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Along with the current clinical trial, the efficacy and safety of ticagrelor and aspirin administered within the first 24 hours of first-ever ischemic stroke compared to cilostazol and aspirin were assessed through NIHSS, mRS, and possible adverse effects.

Detailed description

The investigators will conduct a randomized controlled trial between December 2021 and February 2024 after approval of the ethics committee of the faculty of medicine at Kafr el-Sheik University. The investigators got written informed consent from all eligible patients or their first order of kin before randomization. The study will be composed of 2 arms ticagrelor arm, which consisted of 450 patients who received 180 mg loading dose followed by 90 mg b.i.d from the 2nd to the 90th day), and the cilostazol arm consisted of 450 patients who received (a 200mg loading dose during the first 24 hours of stroke onset followed by 100mg twice daily from the 2nd day to the 90th day), All the patients in the two groups received open-label aspirin at a loading dose of 75 to 300 mg, followed by 75 mg daily for 21 days. Study Procedures: Every patient in our study will undergo: Clinical workup: History, clinical assessment \& NIHSS were recorded on admission, day 7, and the Modified Rankin Scale as a follow-up after one week and 3 months. Detection of Risk Factors \& Profiles: Echocardiography\& TOE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. - Carotid Duplex: carotid duplex in indicated patients. 4- ESR \& Lipid Profile\& liver functions: All will be tested routinely for all patients. Imaging Follow UP Non-contrast CT brain on admission Day 2 MRI: after 2 days of admission, all the patients in this study will have a brain MRI (stroke protocol; T1W, T2W, FLAIR, DWI, T2 Echo Gradient, MRA of all intra-cerebral vessels). CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT. Primary End Point: The primary efficacy outcome was the rate of new stroke at 90 days, and the primary safety outcome was the rate of drug hemorrhagic complications using the PLATO bleeding definition. • Secondary End Point: the secondary efficacy outcomes were to evaluate the rates of patients who achieved a significant reduction in NIHSS (decrease of four points or more) at the seventh day or discharge compared to baseline, the rates of a favorable outcome with (mRS = 0-2) after one week and after 90 days in a face-to-face interview in the outpatient clinic, rates of the composite of recurrent stroke, myocardial infarction and death due to vascular events after 90 days of follow-up, while the secondary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Ticagrelor 90 MG	Efficacy and safety of 180 mg loading dose of ticagrelor administered within 24 hours of first-ever ischemic stroke followed by 90 mg bid for 3 months will be assessed through NIHSS, mRS, new ischemic stroke, and possible adverse effects.
DRUG	Cilostazol 100 MG	Efficacy and safety of 200 mg loading dose of cilostazol administered within 24 hours of first-ever ischemic stroke followed by 100 mg bid for 3 months will be assessed through NIHSS, mRS, new ischemic stroke, and possible adverse effects.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-20
• Completion: 2024-12-30
• First posted: 2024-01-09
• Last updated: 2024-08-20

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study