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Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

Primary Purpose

Ischemic Stroke, Patent Foramen Ovale

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Warfarin
Aspirin
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring cerebrovascular diseases, ischemic stroke, patent foramen ovale, warfarin, aspirin, transesophageal echocardiography

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia College of Physicians and Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Warfarin

Aspirin

Arm Description

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

Aspirin 325 mg plus placebo warfarin

Outcomes

Primary Outcome Measures

Recurrent ischemic stroke and death

Secondary Outcome Measures

Full Information

First Posted
June 11, 2008
Last Updated
September 14, 2011
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00697151
Brief Title
Patent Foramen Ovale in Cryptogenic Stroke Study
Acronym
PICSS
Official Title
Patent Foramen Ovale in Cryptogenic Stroke Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 1993 (undefined)
Primary Completion Date
June 2000 (Actual)
Study Completion Date
June 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Patent Foramen Ovale
Keywords
cerebrovascular diseases, ischemic stroke, patent foramen ovale, warfarin, aspirin, transesophageal echocardiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Aspirin 325 mg plus placebo warfarin
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 325 mg once a day; placebo warfarin once a day
Primary Outcome Measure Information:
Title
Recurrent ischemic stroke and death
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shunichi Homma, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12045168
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 4;105(22):2625-31. doi: 10.1161/01.cir.0000017498.88393.44.
Results Reference
result
PubMed Identifier
15232117
Citation
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.
Results Reference
result
PubMed Identifier
13678932
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. doi: 10.1016/s0735-1097(03)00907-0.
Results Reference
result
PubMed Identifier
19380621
Citation
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.
Results Reference
derived

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Patent Foramen Ovale in Cryptogenic Stroke Study

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