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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 coronary syndrome undergoing elective percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental |
| |
| Heparin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular 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 angina, Ventricular 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 | |
|---|---|---|---|---|
| Shaoke Meng, M.D. | Contact | +86 18098875772 | shaokemeng@dmu.edu.cn | |
| Rongchong Huang, Ph.D. | Contact | +86 18841182000 | rchuang@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Shaoke Meng, 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 | 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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| Heparin | Drug | 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. |
|
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 angina, Ventricular 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 |
| Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 30 days |
| Major bleeding | BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding. | 180days |
| 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. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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