Patent Foramen Ovale in Cryptogenic Stroke Study "PICSS"


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.



  • Warfarin (CoumadinĀ®)Drug
    Other Names: Coumadin
    Intervention Desc: Anticoagulant (Vitamin K antagonist)
  • Aspirin Drug
    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


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