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

Verified by: Hillerod Hospital, Denmark, November 2009
First Received: November 20, 2009 | Last Updated: May 5, 2010 | Phase: N/A | Start Date: October 2009
Overall Status: Terminated | Estimated Enrollment: 3000
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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...

Brief Summary

Official Title: “The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: September 2011

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Device: Percutaneous device closure of patent foramen ovale
    • Percutaneous device closure of patent foramen ovale

Arms, Groups and Cohorts in this Clinical Trial

  • 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
  • Active Comparator: Medical anticoagulative treatment
    • Life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily

Outcome Measures for this Clinical Trial

Primary 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
      Safety Issue?: No

Secondary Measures

  • ct-verified stroke 2 years after intervention
    • Time Frame: 2 years after intervention
      Safety Issue?: No
  • Death by other causes than Stroke
    • Time Frame: Endpoint assessed every half year starting 1 year after intervention
      Safety Issue?: No
  • Examination of residual cardiac right to left shunt after device closure of PFO
    • Time Frame: 1 month after intervention
      Safety Issue?: No
  • Complications to device closure of PFO
    • Time Frame: few days after intervention
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 51 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Hillerod Hospital, Denmark Other

Overall Clinical Trial Officials and Contacts

Christian S Hansen, dr. Principal Investigator Hillerød Hospital. dept. of cardiology and endocrinology  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018355

Study ID Number: Hillerod-294

ClinicalTrials.gov Identifier: NCT01018355

Health Authority: Denmark: Danish Dataprotection Agency

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