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Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| heparin | Active Comparator | For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines. |
|
| not prolong infusion Bivalirudin | Experimental | Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure . |
|
| prolong infusion bivalirudin | Experimental | Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bivalirudin | Drug | Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| creatine kinase-MB increase | creatine kinase-MB increase >3 times upper limit of normal | up to postprocedural 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding(BARC class) | including BARC class 2-5 | 30 days and 1 year |
| major adverse cardiac or cerebral events | a composite of all cause death, reinfarction, target vessel revascularization or stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yundai chen, doctor | Contact | +08613581886786 | dingyutinkle@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChinaPLAGH | Beijing | Beijing Municipality | 1000853 | China | ||
| ChinaPLAGH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25775052 | Background | Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323. | |
| 19801025 |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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 is used in patients undergoing percutaneous coronary intervention. |
|
| 30 days and 1 year |
| Net Adverse Clinical Events | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding | 30 days and 1 year |
| Beijing |
| Beijing Municipality |
| 100853 |
| China |
|
| Result |
| Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005. |