Patent Foramen Ovale in Cryptogenic Stroke Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697151

Acronym

PICSS

Enrollment

630

Registered

2008-06-13

Start date

1993-06-30

Completion date

2000-06-30

Last updated

2011-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke, Patent Foramen Ovale

Keywords

cerebrovascular diseases, ischemic stroke, patent foramen ovale, warfarin, aspirin, transesophageal echocardiography

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.

Interventions

DRUGWarfarin

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

DRUGAspirin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Recurrent ischemic stroke and death	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026