Status:
COMPLETED
Ticagrelor Versus Clopidogrel in Large Vessel Ischemic Stroke
Lead Sponsor:
Kafrelsheikh University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Along with the current clinical trial, the efficacy and safety of 180 mg loading dose of ticagrelor administered within 24 hours of first-ever large-vessel ischemic stroke compared to 300 mg clopidogr...
Detailed Description
The investigators conduct a single-blinded randomized controlled trial between September 2021 and September 2023 after approval of the ethical committee of the faculty of medicine at Kafr el-Sheik Uni...
Eligibility Criteria
Inclusion
- 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
- the 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.
- The investigators excluded patients who were regular users of drugs that affect clopidogrel metabolism, such as proton pump inhibitors, statins, ketoconazole, dihydropyridine calcium channel blockers, and rifampin.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT06120725
Start Date
September 1 2021
End Date
November 1 2023
Last Update
December 29 2023
Active Locations (1)
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1
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt, 33511