RecruitingPhase 3NCT06591351

Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA

Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA, a Randomized Controlled Trial


Sponsor

Kafrelsheikh University

Enrollment

870 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

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 stroke or TIA compared to 200 mg cilostazol and 300 mg loading aspirin were assessed through NIHSS, mRS, and possible adverse effects


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • 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 Criteria6

  • 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

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Interventions

DRUGCilostazol 100 MG

Efficacy and safety of 200 mg cilostazol followed by 100 mg twice daily for three months and loading 300 mg aspirin and 75 mg aspirin maintenance will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects,

DRUGClopidogrel

Efficacy and safety of 300 mg clopidogrel followed by 75mg once daily for three months and loading 300 mg aspirin and 75 mg aspirin maintenance will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects,


Locations(1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt

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NCT06591351


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