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This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.
Bivalirudin is a direct thrombin inhibitor that exhibits a reversible and transient anticoagulant effect. Randomized trials have shown conflicting results for bivalirudin in reducing the risk of bleeding for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI (PPCI) compared to heparin. Recently, the BRIGHT-4 study, which assigned 6016 STEMI patients to bivalirudin with a prolonged high dose infusion or heparin during PPCI, showed bivalirudin decreased the risk of a composite endpoint of all-cause mortality and bleeding. However, few studies have focused on the safety and efficacy of bivalirudin in PCI post-fibrinolysis. We therefore aim to conduct the Bivalirudin With Prolonged Infusion During PCI Versus Heparin Following Fibrinolytic Therapy (BRIGHT-FIT) trial to examine whether bivalirudin with a high-dose infusion in PCI after fibrinolysis in superior to heparin in reducing mortality and major bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | bivalirudin with a prolonged infusion |
|
| Heparin | Active Comparator | Heparin alone during PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | For rescued PCI, do not recommend to include patient who's ACT is more than 350s. If fibrinolysis is successful, monitor ACT and wait till it's lower than 350s before randomization. Monitor ACT before angiography, (1) if ACT<180, bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI; (2) if 180s<ACT<225s, bivalirudin 0.5mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI; (3) if ACT>225s, bivalirudin intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. (4) ACT be monitored 5 minutes after the first administration, and if ACT is <225 s, intravenous injection of 0.3 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause death or BARC type 3、5 bleeding | BARC=Bleeding academic research consortium | 30days |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 30days and 1year | |
| Composite of all-cause death or BARC type 2、3、5 bleeding | BARC=Bleeding academic research consortium | 30days and 1year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Chen, MD | Contact | (86)13891995622 | chentao0331@xjtu.edu.cn | |
| Chenbo Xu, MD | Contact | (86)13468763406 | xuchenbox@qq.com |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Unfractionated heparin | Drug | (1)If ACT<180s, administer an intravenous bolus of unfractionated heparin at 70 U/kg before coronary angiography, with a maximum total dose of 6000U. (2)If 180<ACT<225s, administer an intravenous bolus of unfractionated heparin at 60 U/kg before coronary angiography, with a maximum total dose of 4000U. (3)If ACT>225s, proceed directly with PCI and maintain 225s\ |
|
| Net adverse clinical events (NACE) | NACE is defined as a composite of MACCE or BARC type 3、5 bleeding | 30days and 1year |
| Major adverse cardiac and cerebral events (MACCE) | MACCE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization | 30days and 1year |
| Stent thrombosis | Definite or probable stent thrombosis according to Academic Research Consortium | 30days |
| BARC type 3、5 bleeding | BARC=Bleeding academic research consortium | 30days |
| BARC type 2、3、5 bleeding | BARC=Bleeding academic research consortium | 30days |
| Thrombocytopenia | defined as platelet counts less than 150*10^9/L after treatment | 30days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |