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The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h. |
|
| Heparin monotherapy | Active Comparator | 100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Events | A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | A composite of all cause death, reinfarction, target vessel revascularization or stroke | 30 days |
| Any bleedings (BARC class) | Including all BARC class (class 3-5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiangjing Long, Dr. | Contact | 86-10-58696282 | 840 | longjianjing@salubris.cn |
| Yan Hou, Dr. | Contact | 86-10-58696282 | 821 | houyan@salubris.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology,General Hospital of Shenyang Military Region | Recruiting | Shanyang | Liaoning | 110016 | China |
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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 monotherapy |
|
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| 30 days |