RecruitingPhase 2Phase 3NCT06653348

Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke

De-Escalation of Dual Antiplatelet Therapy With Ticagrelor and Aspirin in Non-disabling Non-cardioembolic Ischemic Stroke or High Risk TIA Patients: A Randomized, Outcome Assessor Blind, Controlled Trial


Sponsor

Mazandaran University of Medical Sciences

Enrollment

100 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, controlled, outcome assessor blind, parallel group design pilot study on 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is to compare the efficacy of 90 mg ticagrelor BID plus aspirin for 1 month and 60 mg ticagrelor BID plus aspirin for 6 months in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months.


Eligibility

Min Age: 40 Years

Inclusion Criteria7

  • signing inform consent,
  • recent ischemic stroke within 24 h,
  • diagnosed by brain CT or MRI mild stroke with NIHSS =\<8 and no evidence of large infarct in brain imaging
  • high risk TIA with ABCD \>4,
  • no cardioembolic source such as low E/F, MS, AF ,...
  • no specific etiology such as dissection, vasculitis, ...
  • no carotid stenosis \> 50 % in side of involvement

Exclusion Criteria9

  • history of hypersensitivity to consumptive drug
  • any indication for anticoagulant therapy
  • acute phase treatment with intravenous thrombolysis or thrombectomy
  • any contraindication for consumptive drug
  • history of intracranial hemorrhage
  • history of GI bleeding during past 6 m
  • candidate for endarterectomy
  • history of coagulopathy
  • active hemorrhagic diathesis during randomization

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Interventions

DRUGTicagrelor 60 + Aspirin

Ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month and then ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 6.

DRUGTicagrelor 90 + aspirin

ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month.


Locations(1)

Mazandaran province, Sari,Iran

Sari, Mazandaran, Iran

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NCT06653348


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