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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
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The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds. |
|
| Heparin | Active Comparator | Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction anginaļ¼Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation. | 7 days |
| Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction anginaļ¼Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation. | 30 days |
| Stent thrombosis ,TVR ,TLR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongchong Huang, M.D. | Contact | +86 411 83635963 | 7127 | rchuang@dlmedu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rongchong Huang, M.D. | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23636477 | Background | De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Parenteral anticoagulants in heart disease: current status and perspectives (Section II). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 May;109(5):769-86. doi: 10.1160/TH12-06-0403. Epub 2013 Mar 28. | |
| 11451763 |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Heparin | Drug | heparin with or without gpi during emergency PCI. |
|
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation |
| 30 days |
| Major adverse cardiac events | a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction anginaļ¼Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation. | 180 days |
| Stent thrombosis ,TVR ,TLR | rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation | 180 days |
| Background |
| Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. AHA Scientific Statement: Guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):E9-9. doi: 10.1161/hq0701.093520. No abstract available. |
| 12087346 | Background | Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002 Jun;71(6):433-9. doi: 10.1067/mcp.2002.124522. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |