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The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard intensity warfarin group | Experimental | standard intensity warfarin group， target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0) |
|
| low intensity warfarin group | Experimental | low intensity warfarin group， target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2) |
|
| dabigatran etexilate group | Active Comparator | 110mg dabigatran etexilate was administrated twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard intensity warfarin | Drug | target international normalised ratio(INR) was 2.1-3.0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ischaemic stroke | ischaemic stroke was defined as a blockage in an artery that supplies blood to the brain , resulting in a deficiency in blood flow and focal neurological deficit lasting >24 hours. | 2 years |
| major haemorrhage | Major haemorrhage was defined as intracranial hemorrhage, gastrointestinal bleeding, bleeding requiring hospitalization and surgical intervention, a reduction of hemoglobin by≥2 g/dL, requiring red blood cells transfusion ≥2 units. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| minor bleeding | 2 years | |
| myocardial infarction | 2 years | |
| pulmonary embolism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wu Jun, doctor | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23200268 | Background | Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available. |
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| low intensity warfarin | Drug | target international normalised ratio(INR) was 1.7-2.2 |
|
| dabigatran etexilate | Drug | 110mg, twice a day, oral |
|
| 2 years |
| cardiovascular death | 2 years |
| all-cause mortality | 2 years |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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