Patent Foramen OvaleCryptoCardNCT01018355
The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI
A study testing Percutaneous device closure of patent foramen ovale in people with Patent Foramen Ovale and PFO, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Patent Foramen Ovale, PFO, Stroke
- What is being tested?
- Percutaneous device closure of patent foramen ovale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke or TIA within 30 days
- Above 50 years of age
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of cardiology and endocrinology H
Hillerød, Region H, 3400
About this study
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.
Read the 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.
- Conditions
- Patent Foramen Ovale, PFO, Stroke, TIA
- Being tested
- Percutaneous device closure of patent foramen ovale
- Keywords
- Patent foramen ovale, PFO, Stroke, TIA, Percutaneus closure, Intervention
- Medical subject headings
- Foramen Ovale, Patent, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous device closure of patent foramen ovaleDevice
Percutaneous device closure of patent foramen ovale
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Percutaneous device closure of patent foramen ovale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint defined by the time from intervention to either fatal og non-fatal stroke/TIA
Measured: Endpoints assessed every half year starting 1 year after intervention
Secondary outcomes (4)
ct-verified stroke 2 years after intervention
Measured: 2 years after intervention
Death by other causes than Stroke
Measured: Endpoint assessed every half year starting 1 year after intervention
Examination of residual cardiac right to left shunt after device closure of PFO
Measured: 1 month after intervention
Complications to device closure of PFO
Measured: few days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Dissatisfactory enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Investigators
- Christian S Hansen, dr., Principal investigator, Hillerød Hospital. dept. of cardiology and endocrinologyNiels Tønder, Dr., Study director, Hillerød Hospital. dept. of cardiology and endocrinologyKasper K Iversen, Dr., Study director, Hillerød Hospital. dept. of cardiology and endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018355
- Sponsor's protocol ID
- Hillerod-294
- Acronym
- CryptoCard
- Status last verified
- Nov 2009
- First submitted
- 20 Nov 2009
- Last updated
- 6 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI
- ClinicalTrials.gov ID
- NCT01018355
- Acronym / sponsor ID
- CryptoCard / Hillerod-294
- Conditions
- Patent Foramen Ovale, PFO, Stroke, TIA
- Keywords
- Patent foramen ovale, PFO, Stroke, TIA, Percutaneus closure, Intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dissatisfactory enrollment rate
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device closure of PFO | Experimental | Device: Percutaneous device closure of patent foramen ovaleDevice 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 |
| Medical anticoagulative treatment | Active comparator | Device: Percutaneous device closure of patent foramen ovaleLife long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke or TIA within 30 days
- Above 50 years of age
Key exclusion criteria (7 listed)
- Deceases og the esophagus
- Dementia
- Allergy to aspirin
- Risk of non-compliance
- Lacking ability to give written or oral consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous device closure of patent foramen ovalePercutaneous device closure of patent foramen ovale | Device | Device closure of PFO, Medical anticoagulative treatment |
Primary outcome
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
4 secondary outcomes
ct-verified stroke 2 years after intervention
Time frame: 2 years after intervention
Death by other causes than Stroke
Time frame: Endpoint assessed every half year starting 1 year after intervention
Examination of residual cardiac right to left shunt after device closure of PFO
Time frame: 1 month after intervention
Complications to device closure of PFO
Time frame: few days after intervention
Results and safety
The study was stopped early (reason given: Dissatisfactory enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Hansen, dr. principal investigator
Hillerød Hospital. dept. of cardiology and endocrinology
Niels Tønder, Dr. study director
Hillerød Hospital. dept. of cardiology and endocrinology
Kasper K Iversen, Dr. study director
Hillerød Hospital. dept. of cardiology and endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous device closure of patent foramen ovale in people with Patent Foramen Ovale and PFO, run by Hillerod Hospital, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Dissatisfactory enrollment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2010.