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CompletedNCT00697151PICSSUpdated Sep 15, 2011

Patent Foramen Ovale in Cryptogenic Stroke Study

A Phase 4 interventional study of Warfarin and Aspirin in Ischemic Stroke and Patent Foramen Ovale, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-09-15.

Sponsored by Columbia University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
630
Allocation
Randomized
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Stroke
  • Patent Foramen Ovale

Keywords

  • cerebrovascular diseases
  • ischemic stroke
  • patent foramen ovale
  • warfarin
  • aspirin
  • transesophageal echocardiography
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's enrollment of 630 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.

Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.

Browse Columbia University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 30-85
  • Ischemic stroke within 30 days
  • Glasgow outcome scale ≥ 3
  • No contraindications to warfarin/aspirin

Exclusion criteria

Exclusion Criteria:

  • Basal INR > 1.4
  • Post-procedural stroke
  • Severe carotid atherosclerosis
  • Cardioembolic stroke
  • Contraindications to transesophageal echocardiography
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
630 participants (actual)

Study arms

  • Active comparator
    Warfarin

    Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin

    Drug: Warfarin

  • Active comparator
    Aspirin

    Aspirin 325 mg plus placebo warfarin

    Drug: Aspirin

Interventions

  • DrugWarfarin

    Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day

    Also known as: Coumadin

  • DrugAspirin

    Aspirin 325 mg once a day; placebo warfarin once a day

06

What researchers measure

Primary outcomes

  1. Recurrent ischemic stroke and death

    Time frame: 2 years

07

Study locations

1 site
  • Columbia College of Physicians and Surgeons
    New York, New York 10032, United States
08

References and documents

Publications

  • 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 4;105(22):2625-31. doi: 10.1161/01.cir.0000017498.88393.44. PubMed 12045168 ↗
  • 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. doi: 10.1161/01.STR.0000135773.24116.18. Epub 2004 Jul 1. PubMed 15232117 ↗
  • 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. doi: 10.1016/s0735-1097(03)00907-0. PubMed 13678932 ↗
  • Di Tullio MR, Russo C, Jin Z, Sacco RL, Mohr JP, Homma S; Patent Foramen Ovale in Cryptogenic Stroke Study Investigators. Aortic arch plaques and risk of recurrent stroke and death. Circulation. 2009 May 5;119(17):2376-82. doi: 10.1161/CIRCULATIONAHA.108.811935. Epub 2009 Apr 20. PubMed 19380621 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00697151
Lead sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
First posted
Jun 13, 2008
Start date
Jun 1993
Primary completion
Jun 2000
Completion
Jun 2000
Last update
Sep 15, 2011

Study contacts

Shunichi Homma, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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