Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

Study Overview
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Brief Summary
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This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.

Official Title
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Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Bivalirudin
* Drug: unfractionated Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any age; STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h; Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin); Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor); The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent. Exclusion Criteria: Not suitable for emergency primary PCI; STEMI treated by thrombolysis; Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI; Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.); Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bivalirudin<br>Bivalirudin with prolonged full dose infusion during primary PCI | Drug: Bivalirudin<br>* Bivaliruding 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. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds.<br>|
| Active Comparator: Heparin<br>Heparin alone during primary PCI | Drug: unfractionated Heparin<br>* Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is >225 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause death or BARC type 3 5 bleeding | BARC=Bleeding academic research consortium | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 30 days | 
| BARC type 3-5 bleeding | BARC=Bleeding academic research consortium | 30 days | 
| Major adverse cardiac and cerebral events (MACE) | MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization | 30 days | 
| Net adverse clinical events (NACE) | NACE is defined as a composite of MACE or BARC type 3-5 bleeding | 30 days | 
| Composite of all-cause death or BARC type 2-5 bleeding | BARC=Bleeding academic research consortium | 30 days | 
| BARC type 2-5 bleeding | BARC=Bleeding academic research consortium | 30 days | 
| Stent thrombosis | Definite or probable stent thrombosis according to Academic Research Consortium | 30 days | 
| Thrombocytopenia | defined as platelet counts less than 150*10^9/L after treatment | 30 days | 
| All cause mortality |  | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin, Primary percutaneous coronary intervention, anticoagulant agents, bivalirudin