Patent Foramen Ovale in Cryptogenic Stroke Study

Ischemic Stroke Clinical Trial

— PICSS  

Official title:

Patent Foramen Ovale in Cryptogenic Stroke Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697151
• Other study ID #: 6372
• Secondary ID: R01NS032525
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2008
• Last updated: September 14, 2011
• Start date: June 1993
• Est. completion date: June 2000

Study information

• Verified date: September 2011
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: June 2000
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 30-85

• Ischemic stroke within 30 days

• Glasgow outcome scale = 3

• No contraindications to warfarin/aspirin

Exclusion Criteria:

• Basal INR > 1.4

• Post-procedural stroke

• Severe carotid atherosclerosis

• Cardioembolic stroke

• Contraindications to transesophageal echocardiography

Study Design

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Ischemic Stroke
• Patent Foramen Ovale
• Stroke

Intervention

Drug:
• Warfarin
Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day
• Aspirin
Aspirin 325 mg once a day; placebo warfarin once a day

Locations

Country	Name	City	State
United States	Columbia College of Physicians and Surgeons	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Homma S, DiTullio MR, Sacco RL, Sciacca RR, Mohr JP; PICSS Investigators. Age as a determinant of adverse events in medically treated cryptogenic stroke patients with patent foramen ovale. Stroke. 2004 Sep;35(9):2145-9. Epub 2004 Jul 1. — View Citation

Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP. Atrial anatomy in non-cardioembolic stroke patients: effect of medical therapy. J Am Coll Cardiol. 2003 Sep 17;42(6):1066-72. — View Citation

Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP; PFO in Cryptogenic Stroke Study (PICSS) Investigators. Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study. Circulation. 2002 Jun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent ischemic stroke and death		2 years	No