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Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

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Trial Profile

Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Dabigatran etexilate (Primary) ; Aspirin
  • Indications Stroke
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RE-SPECT ESUS
  • Sponsors Boehringer Ingelheim; Unilfarma

    • Most Recent Events

    • 15 Oct 2021 Results of a secondary analysis assessing predictors for developing AF and associated recurrent stroke published in the Circulation
    • 28 Jan 2021 Results evalauting whether Patent foramen ovale (PFO) increase the risk of embolic stroke of undetermined source, published in the Stroke
    • 14 May 2020 Results of exploratory subgroup analysis investigating the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding, published in the Stroke.

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