INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority "INVICTUS-ASA"

Not yet recruiting

Phase 3 Results N/A

Trial Description

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

Interventions

  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    ARM 1: Kind: Experimental
    Label: Aspirin (ASA)
    Description: Aspirin 100 mg od (n~1000)
  • Rivaroxaban (15 mg) Drug
    Other Names: Xarelto
    Intervention Desc: 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: Left atrial enlargement ≥ 5.5 cm, OR Left atrial spontaneous echo contrast OR Left atrial thrombus OR Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG.
    ARM 1: Kind: Experimental
    Label: Rivaroxaban (15 mg)
    Description: Rivaroxaban 15 mg od (n ~ 1000)

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Time from randomization to the first occurrence of Stroke or systemic embolism Approximately 4 years No
Secondary Time from randomization to the first occurrence of Myocardial Infarction (MI) Approximately 4 years No
Secondary Time from randomization to time of vascular death Approximately 4 years No

Sponsors