NCT00697151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 1993

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1993

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

7 years

First QC Date

June 11, 2008

Last Update Submit

September 14, 2011

Conditions

Ischemic StrokePatent Foramen Ovale

Keywords

cerebrovascular diseasesischemic strokepatent foramen ovalewarfarinaspirintransesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

  • Recurrent ischemic stroke and death

    2 years

Study Arms (2)

Warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Aspirin

ACTIVE COMPARATOR

Aspirin 325 mg plus placebo warfarin

Drug: Aspirin

Interventions

WarfarinDRUG

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

Also known as: Coumadin
Warfarin
AspirinDRUG

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

Aspirin

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Related Publications (4)

  • 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.

    PMID: 12045168RESULT

  • 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.

    PMID: 15232117RESULT

  • 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.

    PMID: 13678932RESULT

  • 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.

    PMID: 19380621DERIVED

MeSH Terms

Conditions

Ischemic StrokeForamen Ovale, PatentCerebrovascular Disorders

Interventions

WarfarinAspirin

Condition Hierarchy (Ancestors)

StrokeBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHeart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Shunichi Homma, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

June 1, 1993

Primary Completion

June 1, 2000

Study Completion

June 1, 2000

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

US(1)