NCT02832531

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.

Conditions

• Rheumatic Heart Disease

Interventions

Type	Name	Description
DRUG	Rivaroxaban (15 mg)	Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (\>1000/24 hours) on Holter ECG.
DRUG	Aspirin	Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (\>1000/24 hours) on Holter ECG.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-04-01
• Completion: 2022-08-01
• First posted: 2016-07-14
• Last updated: 2022-07-19