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| ID | Type | Description | Link |
|---|---|---|---|
| (KF) 01-080/04 | Other Identifier | Science Ethics Committee Copenhagen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | Aspirin 150mg daily, starting day 1 after surgery, for three months. |
|
| Warfarin | Active Comparator | Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 150mg/daily for three months, starting day after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemorrhagic complications | Bleeding complications | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic findings before surgery, before discharge and 3 months after implantation | 3 months | |
| Registration of surgical data and postoperative complications | 3 months | |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Olsen, MD, DMSc | Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen | Principal Investigator |
| Nikolaj B Lilleør | Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen | Principal Investigator |
| Sulman Rafiq | Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen | Study Chair |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C024079 | aspirin, magnesium oxide combination |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Warfarin | Drug | Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months. |
|
|
| All cause mortality |
| 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |