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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00166257




Registration number
NCT00166257
Ethics application status
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
27/05/2009

Titles & IDs
Public title
PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
Scientific title
Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
Secondary ID [1] 0 0
ICN98008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Embolism, Paradoxical 0 0
Heart Septal Defects, Atrial 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Percutaneous closure of patent foramen ovale
Treatment: Drugs - Medical antitrhombotic treatment

Active Comparator: Medical antitrhombotic treatment -

Experimental: Device Implant - Percutaneous closure of patent foramen ovale


Treatment: Devices: Percutaneous closure of patent foramen ovale
Percutaneous implantation of an AMPLATZER® PFO Occluder

Treatment: Drugs: Medical antitrhombotic treatment
Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to death (Fatal stroke, cardiovascular, non-CV),
Timepoint [1] 0 0
continuosly
Primary outcome [2] 0 0
non-fatal cerebrovascular event,
Timepoint [2] 0 0
continuosly
Primary outcome [3] 0 0
peripheral embolism
Timepoint [3] 0 0
continuosly
Secondary outcome [1] 0 0
New arrhythmias,
Timepoint [1] 0 0
continuosly
Secondary outcome [2] 0 0
myocardial infarction
Timepoint [2] 0 0
continuosly
Secondary outcome [3] 0 0
rehospitalization related to PFO or its treatment
Timepoint [3] 0 0
continuosly
Secondary outcome [4] 0 0
device problems
Timepoint [4] 0 0
continuosly
Secondary outcome [5] 0 0
bleeding complications
Timepoint [5] 0 0
continuosly

Eligibility
Key inclusion criteria
- Age below 60 years

- Ischemic stroke or peripheral thromboembolism, radiologically verified

- Absence of an identifiable cause of embolism

- Echocardiographically verified patent foramen ovale

- Sufficient recovery from index event to allow independent daily activities
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any identifiable cause for thromboembolic event other than PFO

- Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or
mitral stenosis, endocarditis, atrial fibrillation

- Vascular system: significant atherosclerosis or dissection of the aorta, collagen
vascular disease, arteritis, vasculitis

- Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis,
arteriovenous malformations, previous hemorrhage

- Contraindications for antithrombotic or anticoagulant therapy

- Patients already on chronic anticoagulant therapy for another disease

- Previous surgical or percutaneous PFO-closure

- Drug or alcohol abuse

- Pregnancy

- Septicemia or severe infectious disease

- Severe CNS disease

- No informed consent

- Foreseen difficulties with study compliance, especially the long-term follow-up

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2011
Actual
Sample size
Target
Accrual to date
Final
414
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 0 0
Alfred Hospital - Prahan
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment postcode(s) [3] 0 0
- Prahan
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
Country [3] 0 0
Switzerland
State/province [3] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Foundation for Cardiovascular Research, Zurich
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Abbott Medical Devices
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare two treatments strategies to prevent further attacks
in patients who have suffered an stroke or occlusion of a major artery with no obvious reason
other than a persistent small opening between the upper heart chambers
Trial website
https://clinicaltrials.gov/ct2/show/NCT00166257
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bernhard Meier, MD
Address 0 0
Dept. Cardiology, University Hospital Insel, Berne, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00166257