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

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 Overview

• Status: Terminated
• Conditions: Stroke; Patent Foramen Ovale; TIA; PFO
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • Hillerød, Region H, Denmark, 3400
      • Dept. of cardiology and endocrinology H

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Combined endpoint defined by the time from intervention to either fatal og non-fatal stroke/TIA	Endpoints assessed every half year starting 1 year after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
ct-verified stroke 2 years after intervention	2 years after intervention
Death by other causes than Stroke	Endpoint assessed every half year starting 1 year after intervention
Examination of residual cardiac right to left shunt after device closure of PFO	1 month after intervention
Complications to device closure of PFO	few days after intervention

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: November 20, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (Estimate): November 23, 2009

Study Record Updates

• Last Update Posted (Estimate): May 6, 2010
• Last Update Submitted That Met QC Criteria: May 5, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Stroke; Intervention; TIA; PFO; Patent foramen ovale; Percutaneus closure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Foramen Ovale, Patent
• Other Study ID Numbers: Hillerod-294