Ischemic StrokePhase 4PICSSNCT00697151
Patent Foramen Ovale in Cryptogenic Stroke Study
A Phase 4 study testing Warfarin and Aspirin in people with Ischemic Stroke and Patent Foramen Ovale, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Ischemic Stroke, Patent Foramen Ovale
- What is being tested?
- Warfarin and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1993to Jun 2000
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-85
- Ischemic stroke within 30 days
- Glasgow outcome scale ≥ 3
- No contraindications to warfarin/aspirin
Who cannot join
- Basal INR > 1.4
- Post-procedural stroke
- Severe carotid atherosclerosis
- Cardioembolic stroke
- Contraindications to transesophageal echocardiography
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia College of Physicians and Surgeons
New York, New York, 10032
About this study
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.
- Conditions
- Ischemic Stroke, Patent Foramen Ovale
- Keywords
- cerebrovascular diseases, ischemic stroke, patent foramen ovale, warfarin, aspirin, transesophageal echocardiography
- Medical subject headings
- Ischemic Stroke, Foramen Ovale, Patent, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Coumadin
Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day
AspirinDrug
Aspirin 325 mg once a day; placebo warfarin once a day
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Active comparator | Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin Receives: Drug: Warfarin |
| Aspirin | Active comparator | Aspirin 325 mg plus placebo warfarin Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent ischemic stroke and death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJun 1993
- Primary completionJun 2000
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Investigators
- Shunichi Homma, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697151
- Sponsor's protocol ID
- 6372
- Other IDs
- R01NS032525
- Acronym
- PICSS
- Status last verified
- Sep 2011
- First submitted
- 11 Jun 2008
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 12045168Homma 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 15232117Homma 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 13678932Di 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patent Foramen Ovale in Cryptogenic Stroke Study
- ClinicalTrials.gov ID
- NCT00697151
- Acronym / sponsor ID
- PICSS / 6372
- Conditions
- Ischemic Stroke, Patent Foramen Ovale
- Keywords
- cerebrovascular diseases, ischemic stroke, patent foramen ovale, warfarin, aspirin, transesophageal echocardiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 1993
- Primary completion
- Jun 2000 (actual)
- Study completion
- Jun 2000 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin | Active comparator | Drug: WarfarinWarfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin |
| Aspirin | Active comparator | Drug: AspirinAspirin 325 mg plus placebo warfarin |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-85
- Ischemic stroke within 30 days
- Glasgow outcome scale ≥ 3
- No contraindications to warfarin/aspirin
Key exclusion criteria (5 listed)
- Basal INR > 1.4
- Post-procedural stroke
- Severe carotid atherosclerosis
- Cardioembolic stroke
- Contraindications to transesophageal echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarfarinAlso: CoumadinWarfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day | Drug | Warfarin |
| AspirinAspirin 325 mg once a day; placebo warfarin once a day | Drug | Aspirin |
Primary outcome
Recurrent ischemic stroke and death
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
- Results publication: PubMed 12045168Homma 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 publication: PubMed 15232117Homma 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 publication: PubMed 13678932Homma 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.
- Derived from this study: PubMed 19380621Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shunichi Homma, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warfarin and Aspirin in people with Ischemic Stroke and Patent Foramen Ovale, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ischemic stroke and death (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00697151, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2011.