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

This study has been terminated.
(Dissatisfactory enrollment rate)
Sponsor:
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01018355
First received: November 20, 2009
Last updated: May 5, 2010
Last verified: November 2009

November 20, 2009
May 5, 2010
October 2009
September 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018355 on ClinicalTrials.gov Archive Site
  • ct-verified stroke 2 years after intervention [ Time Frame: 2 years after intervention ] [ Designated as safety issue: No ]
  • Death by other causes than Stroke [ Time Frame: Endpoint assessed every half year starting 1 year after intervention ] [ Designated as safety issue: No ]
  • Examination of residual cardiac right to left shunt after device closure of PFO [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
  • Complications to device closure of PFO [ Time Frame: few days after intervention ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Patent Foramen Ovale
  • PFO
  • Stroke
  • TIA
Device: Percutaneous device closure of patent foramen ovale
Percutaneous device closure of patent foramen ovale
  • 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
    Intervention: Device: 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
    Intervention: Device: Percutaneous device closure of patent foramen ovale
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3000
June 2015
September 2011   (final data collection date for primary outcome measure)

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
Both
51 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01018355
Hillerod-294
Yes
Christian Stevns Hansen / Dr. of medicine, Ph.d. student, Department of cardiology and endocrinology at Hillerød Hospital, Denmark
Hillerod Hospital, Denmark
Not Provided
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
Hillerod Hospital, Denmark
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP