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

Stroke Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01018355
• Other study ID #: Hillerod-294
• Status: Terminated
• Phase: N/A
• First received: November 20, 2009
• Last updated: May 5, 2010
• Start date: October 2009
• Est. completion date: June 2015

Study information

• Verified date: November 2009
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3000
• Est. completion date: June 2015
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale
• PFO
• Stroke
• TIA

Intervention

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

Locations

Country	Name	City	State
Denmark	Dept. of cardiology and endocrinology H	Hillerød	Region H

Sponsors (1)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	ct-verified stroke 2 years after intervention		2 years after intervention	No
Secondary	Death by other causes than Stroke		Endpoint assessed every half year starting 1 year after intervention	No
Secondary	Examination of residual cardiac right to left shunt after device closure of PFO		1 month after intervention	No
Secondary	Complications to device closure of PFO		few days after intervention	Yes