Status:
RECRUITING
Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA
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 a 300 mg loading dose of clopidogrel and 300 mg loading aspirin administered within 24 hours of the first-ever large-vessel minor stro...
Detailed Description
The investigators conducted a single-blinded randomized controlled trial after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it. The investigators got written i...
Eligibility Criteria
Inclusion
- the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with large-vessel minor ischemic stroke or TIA who received antiplatelet treatment within the first 24 hours of the onset of ischemic stroke. 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 \< 5 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2024
Estimated Enrollment :
870 Patients enrolled
Trial Details
Trial ID
NCT06591351
Start Date
May 1 2022
End Date
October 10 2024
Last Update
September 19 2024
Active Locations (1)
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1
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt, 33511