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Bivalirudin is widely used as an anticoagulant to reduce the risk of bleeding in PCI perioperative period. Additionally, 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI), so bivalirudin was used to anticoagulate in these patients to evaluate its safety and efficacy.
Bivalirudin is a specific reversible thrombin direct inhibitor and the function of thrombin activity site can be recovered through hydrolyzing bivalirudin by thrombin. Therefore, bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease, and 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI). At the same time, elderly patients have higher risk of bleeding whose age over 65, so bivalirudin can reduce the risk of bleeding and the incidence of net adverse clinical events for the elderly patients whose age over 65 with diabetes mellitus in PCI perioperative period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective PCI with bivalirudin | Experimental | Before PCI, bivalirudin is intravenously injected with 0.75 mg/kg, 1.75 mg/(kg.h) through continuous intravenous drip to finish surgery (no more than 4 hours), if necessary, after the surgery, with a low dose of 0.2 mg/(kg.h) intravenous drip less than 20 hours. |
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| Unfractionated heparin | Placebo Comparator | Before PCI, unfractionated heparin sodium is intravenously injected with 70-100 U/kg, and if the operation time exceeded 1h, an additional 1000 U/h would be added. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective PCI | Procedure | Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus. |
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| Measure | Description | Time Frame |
|---|---|---|
| activated clotting time(ACT) | The ACT test can be used to monitor anticoagulation effects, such as high-dose heparin before, during, and shortly after procedures that require intense anticoagulant administration, such as cardiac bypass, cardiac angioplasty, thrombolysis, extra-corporeal membrane oxygenation (ECMO) and continuous dialysis | 5min after using drug |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day major adverse cardiac events | 30-day major adverse cardiac events including recidivation of angina pectoris, in-stent restenosis, severe arrhythmia, cardiac failure, sudden cardiac death. | 30 days |
| 30-day bleeding events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Gong, Master | Contact | 15583407654 | 1500113940@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Qian Gong, Master | Mian Yang Central Hospital | Study Chair |
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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 |
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| Bivalirudin | Drug | Before, during and after surgery, bivalirudin was used according to the dosage regimen to assess it's impact on elderly patients with diabetes mellitus undergoing selective PCI. |
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According to the bleeding academic research consortium (BARC) bleeding classification.
| 30 days |