ThromboembolismPhase 4NCT01452568
Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
A Phase 4 study testing Aspirin and Warfarin in people with Thromboembolism and Bleeding, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial. The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thromboembolism, Bleeding
- What is being tested?
- Aspirin and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Mar 2012
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery.
- Age 60 years Sinus rhythm
Who cannot join
- Patients planned for double valve surgery
- Patients with active endocarditis
- Patients with atrial fibrillation/flutter
- Patients in anticoagulation treatment of other reason.
- Patients with previous cerebrovascular accidents or insults.
- Patients with TCI
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- Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable
- Patients with pacemaker
- Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer
- Patients that is HIV-positive or have active AIDS
- Patients that are known drug abuser
- Patients in chronic haemodialysis or other types of dialysis
About this study
Official title: Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin
The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial.
The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.
- Conditions
- Thromboembolism, Bleeding
- Keywords
- Thromboembolic complications, Bleeding complications, Haemorrhagic complications, Anticoagulant therapy, Aspirin, biological Aorta Valve
- Medical subject headings
- Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Magnyl, Acetyl salicylic acid
150mg/daily for three months, starting day after surgery
WarfarinDrug
Also called marevan
Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin 150mg daily, starting day 1 after surgery, for three months. Receives: Drug: Aspirin |
| Warfarin | Active comparator | Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemorrhagic complications
Bleeding complications
Measured: 3 months
Thromboembolic complications
TCI, stroke, Myocardial infarction (MI), Pulmonary embolism, Deep vein thrombosis (DVT) , peripheral arterial embolism, intra-cardiac thrombus formation. We expected statistically fewer thromboembolic events in the groups receiving anticoagulation with warfarin than the aspirin only groups.
Measured: 3 months
Secondary outcomes (3)
Echocardiographic findings before surgery, before discharge and 3 months after implantation
Measured: 3 months
Registration of surgical data and postoperative complications
Measured: 3 months
All cause mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startJun 2005
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaj B. Lilleoer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Peter S Olsen, MD, DMSc, Principal investigator, Cardiothoracic Surgery, Rigshospitalet, University of CopenhagenNikolaj B Lilleør, Principal investigator, Cardiothoracic Surgery, Rigshospitalet, University of CopenhagenSulman Rafiq, Study chair, Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452568
- Sponsor's protocol ID
- 01-080/04
- Other IDs
- (KF) 01-080/04
- Status last verified
- Aug 2014
- First submitted
- 22 Sep 2009
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin
- ClinicalTrials.gov ID
- NCT01452568
- Acronym / sponsor ID
- 01-080/04
- Conditions
- Thromboembolism, Bleeding
- Keywords
- Thromboembolic complications, Bleeding complications, Haemorrhagic complications, Anticoagulant therapy, Aspirin, biological Aorta Valve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Oct 2011 (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 optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial.
The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinAspirin 150mg daily, starting day 1 after surgery, for three months. |
| Warfarin | Active comparator | Drug: WarfarinWarfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery.
- Age 60 years Sinus rhythm
Key exclusion criteria (12 listed)
- Patients planned for double valve surgery
- Patients with active endocarditis
- Patients with atrial fibrillation/flutter
- Patients in anticoagulation treatment of other reason.
- Patients with previous cerebrovascular accidents or insults.
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 |
|---|---|---|
| AspirinAlso: Magnyl, Acetyl salicylic acid150mg/daily for three months, starting day after surgery | Drug | Aspirin |
| WarfarinAlso: marevanWarfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months. | Drug | Warfarin |
Primary outcome
Haemorrhagic complications
Time frame: 3 months
Bleeding complications
Thromboembolic complications
Time frame: 3 months
TCI, stroke, Myocardial infarction (MI), Pulmonary embolism, Deep vein thrombosis (DVT) , peripheral arterial embolism, intra-cardiac thrombus formation. We expected statistically fewer thromboembolic events in the groups receiving anticoagulation with warfarin than the aspirin only groups.
3 secondary outcomes
Echocardiographic findings before surgery, before discharge and 3 months after implantation
Time frame: 3 months
Registration of surgical data and postoperative complications
Time frame: 3 months
All cause mortality
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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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.
Peter S Olsen, MD, DMSc principal investigator
Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
Nikolaj B Lilleør principal investigator
Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
Sulman Rafiq study chair
Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Warfarin in people with Thromboembolism and Bleeding, run by Copenhagen University Hospital, Rigshospitalet.
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 12 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: finished, as of the sponsor's last update on 5 Aug 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Haemorrhagic complications (time frame: 3 months). The study lists 2 primary outcomes in all. 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 5 Aug 2014.