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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)

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: 09 Oct 2019

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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

    • 24 May 2019 Planned number of patients changed from 6000 to 6750.
    • 16 May 2019 Primary endpoint (Time to first recurrent stroke (ischemic, hemorrhagic, or unspecified)) has not been met, according to the results published in the New England Journal of Medicine
    • 16 May 2019 Results published in the New England Journal of Medicine
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