Heart Valve DiseasePhase 4NCT00187304
ACTION - Anticoagulation Treatment Influence on Post-operative Patients
A Phase 4 study testing Aortic valve replacement in people with Heart Valve Disease, run by Abbott Medical Devices.
Trial summary
The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- Aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
- Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
- Patient is of legal age in the host country
- The patient is in sinus rhythm before implantation
Who cannot join
- Patient already has a prosthetic valve, other than the valve being replaced at this time.
- Patient requires double valve implantation
- Patient requires concomitant CABG
- Patients requires intra aortic balloon pump at intervention
- Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis)
- Patient requires ASA or AVK therapy, i.e. not suitable for randomization
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- Patient is pregnant or nursing.
- Patient is affected by active endocarditis.
- Patient is affected by aortic dissection.
- Patient has history of cerebral ischemia
- Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk
- Patient is affected by peripheral vascular disease requiring treatment
- Patient has previous chronic anticoagulation therapy
- Patient is allergic to ASA and/or AVK
About this study
Official title: Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial
The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).
- Conditions
- Heart Valve Disease
- Being tested
- Aortic valve replacement
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacementDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
Why it stopped: Study replaced by an observational study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Phillippe Verhoye, MD, Principal investigator, CHU Pontchaillou Rennes France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187304
- Sponsor's protocol ID
- CS04012TV
- Status last verified
- Feb 2019
- First submitted
- 15 Sep 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial
- ClinicalTrials.gov ID
- NCT00187304
- Acronym / sponsor ID
- CS04012TV
- Conditions
- Heart Valve Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study replaced by an observational study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- First posted
- 16 Sep 2005 (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 of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
- Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
- Patient is of legal age in the host country
- The patient is in sinus rhythm before implantation
Key exclusion criteria (14 listed)
- Patient already has a prosthetic valve, other than the valve being replaced at this time.
- Patient requires double valve implantation
- Patient requires concomitant CABG
- Patients requires intra aortic balloon pump at intervention
- Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis)
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 |
|---|---|---|
| Aortic valve replacement | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
Jean-Phillippe Verhoye, MD principal investigator
CHU Pontchaillou Rennes France
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aortic valve replacement in people with Heart Valve Disease, run by Abbott Medical Devices.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 4 Feb 2019.