Ticagrelor Versus Clopidogrel in Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Along with the current clinical trial, the efficacy and safety of 180 mg loading dose of
      ticagrelor administered within the first 24 hours of first-ever ischemic stroke compared to
      300 mg clopidogrel were assessed through NIHSS, mRS, duration of hospital stay, and possible
      adverse effects.
    

Detailed description: 
      The investigators will conduct a single-blinded randomized controlled trial between October
      2022 and December 2023 after approval of the ethical 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 a 180 mg loading dose followed by 90 mg b.i.d from the 2nd to the 90th day), and the
      Clopidogrel arm consisting of 450 patients who received (a 300 mg loading dose during the
      first 24 hours of stroke onset followed by 75 mg once daily from the 2nd day to the 90th day)

      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:

             1. Echocardiography& TOE: in indicated patients

             2. ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3-
                Carotid Duplex: carotid duplex in indicated patients.

           4- ESR & Lipid Profile& liver functions: All will be tested routinely for all patients.

        -  Imaging Follow UP

             1. Non-contrast CT brain on admission

             2. 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).

             3. 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 ischemic 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) (21) at the
      seventh day or discharge compared to baseline, the rates of a favourable outcome with (mRS =
      0-2) (19,20) after one week and after 90 days in a face-to-face interview in the outpatient
      clinic, rates of 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.
    

Intervention name(s): Ticagrelor 90 MG Oral Tablet; Clopidogrel tablet
Intervention type(s): Drug; Drug
Intervention description(s): 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, duration of hospital stay, new ischemic stroke, and possible adverse effects.; efficacy and safety of 300 mg clopidogrel followed by 75 mg once daily for 3 months will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke and possible adverse effects.
Other intervention name(s): group A; group B
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We will conduct our randomized controlled trial, which will contain 2 arms; the ticagrelor arm (group A) will receive (a 180 mg loading dose during the first 24 hours of stroke onset, followed by 90 mg b.i.d from the 2nd to the 90th day), and the Clopidogrel arm will receive (300 mg loading dose during the first 24 hours of stroke onset followed by 75 mg once daily from the 2nd day to the 90th day).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ticagrelor; clopidogrel; ischemic stroke; egypt; kafr el-sheikh faculty of medicine