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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2022

Primary Completion Date

April 30, 2022

Study Completion Date

August 31, 2022

Conditions
Rheumatic Heart Disease
Interventions
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."

All Listed Sponsors
collaborator

University of Cape Town

OTHER

lead

Population Health Research Institute

OTHER

NCT02832531 - INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority | Biotech Hunter | Biotech Hunter