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A Prospective, Multicentre, Randomized, Open Label, Blinded Endpoint, Phase 3 Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr with Acetylsalicylic Acid versus CLopidogrel with Acetylsalicylic Acid in the Development of Cerebrovascular EMbolic Events during Transcatheter Aortic Valve Implantation (TAVI) OperationS

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Trial Profile

A Prospective, Multicentre, Randomized, Open Label, Blinded Endpoint, Phase 3 Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr with Acetylsalicylic Acid versus CLopidogrel with Acetylsalicylic Acid in the Development of Cerebrovascular EMbolic Events during Transcatheter Aortic Valve Implantation (TAVI) OperationS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jul 2021

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At a glance

  • Drugs Ticagrelor (Primary) ; Aspirin; Clopidogrel
  • Indications Intracranial embolism
  • Focus Therapeutic Use
  • Acronyms PTOLEMAIOS
  • Most Recent Events

    • 06 Jul 2021 Primary endpoint has been met. (The number of confirmed HITS, as assessed by Transcranial Doppler (TCD), between the two treatment groups during the TAVI procedure.), as per Results published in the American Journal of Cardiology
    • 06 Jul 2021 Results published in the American Journal of Cardiology
    • 01 Mar 2021 Status changed from recruiting to completed.

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