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

NCT01018355 | Terminated DMC

• 1 other identifier: Hillerod-294
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patent Foramen Ovale; PFO; Stroke; TIA

Keywords

Patent foramen ovale; PFO; Stroke; TIA; Percutaneus closure; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Device closure of PFO

EXPERIMENTAL

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

Medical anticoagulative treatment

ACTIVE COMPARATOR

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

Device: Percutaneous device closure of patent foramen ovale

Interventions

Percutaneous device closure of patent foramen ovale DEVICE

Percutaneous device closure of patent foramen ovale

Device closure of PFO; Medical anticoagulative treatment

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead

Study Sites (1)

Dept. of cardiology and endocrinology H

Hillerød, Region H, 3400, Denmark

Location

MeSH Terms

Conditions

Foramen Ovale, Patent; Stroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Christian S Hansen, dr.

  Hillerød Hospital. dept. of cardiology and endocrinology

  PRINCIPAL INVESTIGATOR

• Niels Tønder, Dr.

  Hillerød Hospital. dept. of cardiology and endocrinology

  STUDY DIRECTOR

• Kasper K Iversen, Dr.

  Hillerød Hospital. dept. of cardiology and endocrinology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: June 1, 2015
• Last Updated: May 6, 2010

Record last verified: 2009-11

Locations

DK (1)