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

Hillerod Hospital, Denmark

Status: Terminated

Conditions: TIA; Stroke; PFO; Patent Foramen Ovale

Treatments: Device: Percutaneous device closure of patent foramen ovale

Study type: Interventional

Funder types: Other

Identifiers

NCT01018355

Hillerod-294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 51+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Device closure of PFO

Experimental group

Description:

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

Treatment:

Device: Percutaneous device closure of patent foramen ovale

Medical anticoagulative treatment

Active Comparator group

Description:

Life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily

Treatment:

Device: Percutaneous device closure of patent foramen ovale