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| Name | Class |
|---|---|
| Karolinska Trial Alliance | INDUSTRY |
| Swedish Heart Lung Foundation | OTHER |
| The Swedish Research Council | OTHER_GOV |
| Stockholm County Council ALF/PPG |
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The optimal anticoagulant for the treatment of left ventricular (LV) thrombus following acute myocardial infarction (AMI) is unclear. The aim of this multicenter randomized study is to evaluate the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with LV thrombus after AMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | Apixaban 5 mg twice a day, reduced to 2.5 mg twice a day for participants with any 2 of following criteria: age > 80 years, serum creatinine > 133 μmol/L or body weight <60 kg. Participants with severe renal failure defined as creatinine clearance 15-29 ml/min/1.73 m2, should also receive the reduced dose of 2.5 mg twice a day. |
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| Warfarin | Active Comparator | Warfarin 2,5 mg once daily with individual dosing according to coagulation assays with an international normalized ratio (INR) goal of 2.0-3.0. Bridging with low-molecular-weight-heparin with a dose of dalteparin 200 units/kg but maximum 18 000 units or enoxaparin 150 units/kg, until therapeutic INR is recommended. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | 5 mg tablet twice a daily with dose reduction according to label |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of participants with thrombus resolution at 3 months | Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE*) at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically relevant bleeding at 3 and 12 months | Clinical relevant bleeding defined as Bleeding Academy Research Consortium (BARC) 2, 3 or 5 bleeding. The BARC bleeding scale ranges from 0 to 5, where 0 is equal to no bleeding, with increasing severity from 1 through 5, where 5 represents fatal bleeding. Major bleeding is most often defined as BARC 3 and 5. BARC 4 bleeding is coronary artery bypass grafting (CABG) related bleeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Olofsson | Contact | +46707780897 | moa.simonsson@ki.se | |
| Stina Smetana | Contact | +46725841182 | stina.smetana@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Moa Simonsson, MD, PhD | Department of Medicine Solna, Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Falu lasarett | Not yet recruiting | Falun | Sweden |
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| UNKNOWN |
Investigator-initiated, multicenter, open-label, blinded outcome assessment, parallel arm, active comparator, randomized study
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Assessment of the primary outcome of thrombus resolution will be performed through review of images by researchers who are blinded to the treatment assignment
| Warfarin | Drug | 2.5 mg tablet once daily, with individual dosing according to coagulation tests |
|
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| 3 and 12 months |
| Severe bleeding at 3 and 12 months | Severe bleeding defined as BARC 3 or 5. For definition of the BARC bleeding scale please see Outcome 2 above. | 3 and 12 months |
| Separate bleeding outcomes at 3 and 12 months | Separate bleeding outcomes defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding | 3 and 12 months |
| Major adverse cardiovascular outcomes (MACE) at 3 and 12 months | MACE is defined as a composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death | 3 and 12 months |
| Stroke or systemic embolism at 3 and 12 months | Composite of ischemic stroke or systemic embolism | 3 and 12 months |
| LV thrombus status at 12 months | Recurrence (or in absence of resolution of LV thrombus at 3 months, persistence) of LV thrombus on TTE at 12 months | 12 months |
| Net adverse clinical outcomes | Composite of MACE and. BARC 2, 3 or 5 bleeding. For definition of MACE and BARC bleeding scale please see Outcome 2 and 5 above. | 3 and 12 months |
| Sahlgrenska University hospital, Mölndal | Not yet recruiting | Gothenburg | Sweden |
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| Sahlgrenska University hospital, Östra | Not yet recruiting | Gothenburg | Sweden |
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| Sahlgrenska University hospital | Not yet recruiting | Gothenburg | Sweden |
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| Linköping University hospital | Not yet recruiting | Linköping | Sweden |
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| Skånes Universitetssjukhus Lund | Recruiting | Lund | Sweden |
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| Skånes University hospital, Malmö | Not yet recruiting | Malmö | Sweden |
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| Vrinnevi hospital | Not yet recruiting | Nörrköping | Sweden |
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| Örebro University hospital | Not yet recruiting | Örebro | Sweden |
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| Karolinska Insitutet | Recruiting | Stockholm | 17177 | Sweden |
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| Danderyds hospital | Not yet recruiting | Stockholm | Sweden |
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| Karolinska Univerity Hospital | Recruiting | Stockholm | Sweden |
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| Sankt Görans Hospital | Not yet recruiting | Stockholm | Sweden |
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| Södersjukhuset | Not yet recruiting | Stockholm | Sweden |
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| Uppsala Akademiska hospital | Not yet recruiting | Uppsala | Sweden |
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| Västmanlands hospital, Västerås | Not yet recruiting | Västerås | Sweden |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| 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 |
| D010847 | Picolines |
| D011725 | Pyridines |
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