NCT00166257

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 Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
414

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_4

Geographic Reach
3 countries

5 active sites

Status
unknown

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

February 1, 2000

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 27, 2009

Status Verified

May 1, 2009

Enrollment Period

11 years

First QC Date

September 9, 2005

Last Update Submit

May 26, 2009

Conditions

Embolism, ParadoxicalHeart Septal Defects, Atrial

Keywords

Paradoxical embolism, Patent foramen ovale,

Outcome Measures

Primary Outcomes (3)

  • Time to death (Fatal stroke, cardiovascular, non-CV),

    continuosly

  • non-fatal cerebrovascular event,

    continuosly

  • peripheral embolism

    continuosly

Secondary Outcomes (5)

  • New arrhythmias,

    continuosly

  • myocardial infarction

    continuosly

  • rehospitalization related to PFO or its treatment

    continuosly

  • device problems

    continuosly

  • bleeding complications

    continuosly

Study Arms (2)

Medical antitrhombotic treatment

ACTIVE COMPARATOR
Drug: Medical antitrhombotic treatment

Device Implant

EXPERIMENTAL

Percutaneous closure of patent foramen ovale

Device: Percutaneous closure of patent foramen ovale

Interventions

Percutaneous closure of patent foramen ovaleDEVICE

Percutaneous implantation of an AMPLATZER® PFO Occluder

Device Implant
Medical antitrhombotic treatmentDRUG

Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d

Medical antitrhombotic treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Monash Medical Centre

Melbourne, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Australia

Location

Alfred Hospital

Prahan, Australia

Location

Universitätsklinik für Innere Medizin II

Vienna, 1090, Austria

Location

A.Z. Sint-Jan AV

Bruges, 8000, Belgium

Location

University Hospital / Inselspital

Bern, Switzerland

Location

Related Publications (2)

  • Meier B, Kalesan B, Mattle HP, Khattab AA, Hildick-Smith D, Dudek D, Andersen G, Ibrahim R, Schuler G, Walton AS, Wahl A, Windecker S, Juni P; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med. 2013 Mar 21;368(12):1083-91. doi: 10.1056/NEJMoa1211716.

    PMID: 23514285DERIVED

  • Khattab AA, Windecker S, Juni P, Hildick-Smith D, Dudek D, Andersen HR, Ibrahim R, Schuler G, Walton AS, Wahl A, Mattle HP, Meier B. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials. 2011 Feb 28;12:56. doi: 10.1186/1745-6215-12-56.

    PMID: 21356042DERIVED

MeSH Terms

Conditions

Embolism, ParadoxicalHeart Septal Defects, AtrialForamen Ovale, Patent

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bernhard Meier, MD

    Dept. Cardiology, University Hospital Insel, Berne, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

February 1, 2000

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

May 27, 2009

Record last verified: 2009-05

Locations

CH(1)BE(1)AU(3)