The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI (CryptoCard)

This study has been terminated.
(Dissatisfactory enrollment rate)
Sponsor:
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01018355
First received: November 20, 2009
Last updated: May 5, 2010
Last verified: November 2009
  Purpose

The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.


Condition Intervention
Patent Foramen Ovale
PFO
Stroke
TIA
Device: Percutaneous device closure of patent foramen ovale

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI

Resource links provided by NLM:


Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Combined endpoint defined by the time from intervention to either fatal og non-fatal stroke/TIA [ Time Frame: Endpoints assessed every half year starting 1 year after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ct-verified stroke 2 years after intervention [ Time Frame: 2 years after intervention ] [ Designated as safety issue: No ]
  • Death by other causes than Stroke [ Time Frame: Endpoint assessed every half year starting 1 year after intervention ] [ Designated as safety issue: No ]
  • Examination of residual cardiac right to left shunt after device closure of PFO [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
  • Complications to device closure of PFO [ Time Frame: few days after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: October 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device closure of PFO
Device closure of PFO followed by 6 month treatment with clopidogrel 75 mg and 75 - 150 mg of aspirin daily followed by a life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily
Device: Percutaneous device closure of patent foramen ovale
Percutaneous device closure of patent foramen ovale
Active Comparator: Medical anticoagulative treatment
Life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily
Device: Percutaneous device closure of patent foramen ovale
Percutaneous device closure of patent foramen ovale

Detailed Description:

Prior to birth the fetal heart has a connection between the two atrias of the heart. After labour this connection often closes. About 10-15 % these connections remains open. This phenomenon is called patent foramen ovale or PFO, and is in most cases unsymptomatic.

The prevalence of PFO in patients with crytogenic (without known causes) stroke is much higher (about 40%)than the general population (about 10%). This has led to the theory that the presence of PFO can lead to stroke, by the passage of emboli from the peripheral venous circulation through the PFO to the brain by right-to-left shunting of the blood.

There are no existing data from prospective randomized studies focusing on the effect of device closure PFO in patients with cryptogenic stroke. Some observational retrospective studies have shown a beneficial effect in the reduction of recurrent stoke in patients younger that 50 years with cryptogenic stroke when PFO has been closed with a percutaneous device closure(PCD). Some studies have reported an 0% to 3.4% annual recurrence rate of stroke or TIA in patients treated with PDC. The recurrence rate of stroke or TIA in patients with crytogenic stroke or TIA in ordinary antithrombotic treatment is about 5-15 %.

The primary objective of this study is to assess whether percutaneous device closure of patent foramen ovale is superior to conventional antithrombotic treatment in preventing stroke recurrence in elderly patients above 50 years of age.

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stroke or TIA within 30 days
  • Above 50 years of age

Exclusion Criteria:

  • Deceases og the esophagus
  • Dementia
  • Allergy to aspirin
  • Risk of non-compliance
  • Lacking ability to give written or oral consent
  • Atrial Fibrillation
  • Neurological deficit lasting less than 6 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018355

Locations
Denmark
Dept. of cardiology and endocrinology H
Hillerød, Region H, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Investigators
Principal Investigator: Christian S Hansen, dr. Hillerød Hospital. dept. of cardiology and endocrinology
Study Director: Niels Tønder, Dr. Hillerød Hospital. dept. of cardiology and endocrinology
Study Director: Kasper K Iversen, Dr. Hillerød Hospital. dept. of cardiology and endocrinology
  More Information

No publications provided

Responsible Party: Christian Stevns Hansen / Dr. of medicine, Ph.d. student, Department of cardiology and endocrinology at Hillerød Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01018355     History of Changes
Other Study ID Numbers: Hillerod-294
Study First Received: November 20, 2009
Last Updated: May 5, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Hillerod Hospital, Denmark:
Patent foramen ovale
PFO
Stroke
TIA
Percutaneus closure
Intervention

Additional relevant MeSH terms:
Foramen Ovale, Patent
Stroke
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014