Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events

• Status: Completed
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Venous thromboembolism affects around 10 million people per year worldwide, however, despite its high incidence, there is no systematic review or randomized trial focused on the treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism (PE) during anticoagulant treatment. The objective was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in patients with recurrent venous thromboembolism treated with rivaroxaban.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Mexicano del Seguro Social
• Treatments: Acenocoumarol; Aspirin; Rivaroxaban; Vitamin K

Criteria

Inclusion Criteria:

Objectively proven first episode of venous thromboembolism (upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis, or pulmonary embolism).

Objectively documented recurrent venous thromboembolism (either new or extended upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis or pulmonary embolism) while taking systemic anticoagulation medication (Rivaroxaban).

Exclusion Criteria:

Previous hemorrhagic stroke Ischemic stroke in the last 3 months Severe renal impairment (CrCl rates < 30 ml/min) Active liver disease (any etiology) Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc.) Increased risk of bleeding (congenital or acquired) Uncontrolled SAH Gastrointestinal hemorrhage within the past year Anemia (Hb level < 10 g/dl) or thrombocytopenia (platelet count < 100 × 109/l) Pregnant or lactating women