Ticagrelor Versus Cilostazol in Ischemic Stroke
NCT Number: NCT06561867
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Ischemic Stroke
Interventions: DRUG: Ticagrelor 90 MG|DRUG: Cilostazol 100 MG
Sponsor: Kafrelsheikh University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-12-20
Locations: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, 33511, Egypt

Summary:
Along with the current clinical trial, the efficacy and safety of a 180 mg loading dose of ticagrelor administered within 24 hours of the first-ever moderate and moderate to severe ischemic stroke compared to 200 mg cilostazol were assessed through NIHSS, mRS, and possible adverse effects.

Primary Outcome Measures: rate of new stroke, Rates of new stroke occur within three months of treatment. The investigators will perform follow-ups of the patient during visits to the outpatient clinic, and brain CT and/ or MRI will be done if there is suspicion of new stroke., 90 days|Rate of drug-related hemorrhagic complications, the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin \> 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites., 90 days
Secondary Outcome Measures: Value of Modified Rankin Scale (mRS) at one week, mRS Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability; its value ranges from 0 to 6; the lower the score, the better the stroke outcome. A favorable stroke outcome is considered with mRS value equals two or less, 7 days|value of Modified Rankin Scale(mRS) at three months, rmRS Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability; its value ranges from 0 to 6; the lower the score, the better the stroke outcome. A favorable stroke outcome is considered with mRS value equal to two or less., 3 months|rate of composite recurrent stroke, myocardial infarction, and death due to vascular events, Rates of new stroke, TIA, myocardial infarction, or death from vascular events within three months of treatment, the investigators will perform follow-ups of the patient during visits to the outpatient clinic and perform needed investigations such as brain imaging, Electrocardiography, arterial and venous duplex ultrasound imaging, 3 months|rate of drug adverse effects, Drug adverse effects: all side effects related to the drugs of our study will be reported, 3 months