Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Venous Thromboembolism
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: randomized, controlled, double-blindMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: over-encapsulated rivaroxaban/ASAPrimary Purpose: Prevention

Participation Requirements

Age
Between 16 years and 125 years
Gender
Both males and females

Description

Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone. This study w...

Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone. This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.

Tracking Information

NCT #
NCT04075240
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • Nova Scotia Health Authority
  • Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Investigators
Principal Investigator: Sudeep P Shivakumar, MD Dalhousie University/Nova Scotia Health Authority