Bivalirudin in Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Bivalirudin
* Drug: heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 80 years old Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Provide written informed consent. Exclusion Criteria: Age <18 or >80 years. Any anticoagulant drugs were regularly used within 3 months. Any anticoagulant agents were used 48 h before randomization. Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc. Hemoglobin < 90 g/L or platelet count < 100 * 109 / L. Untreated or uncontrolled hypertension > 180/110 mmHg. Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2). Heparin induced thrombocytopenia. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. Pregnancy , lactation or plan to be pregnant. Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time < 6 months. Unsuitable for PCI. Attended any clinical trial 1 month before randomised.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 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. | Drug: Bivalirudin<br>* Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.<br>* Other names: Taijianing;|
| Active Comparator: Heparin monotherapy<br>100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given. | Drug: heparin<br>* heparin monotherapy<br>* Other names: Gansu;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty