Patent Foramen Ovale in Cryptogenic Stroke Study "PICSS"

Completed

Phase 4 Results N/A

Trial Description

The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.

Conditions

Interventions

  • Warfarin (CoumadinĀ®)Drug
    Intervention Desc: Anticoagulant (Vitamin K antagonist)
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrent ischemic stroke and death 2 years No

Sponsors