Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Study Overview
=================
Brief Summary
-----------------
Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Detailed Description
-----------------
Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Official Title
-----------------
Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Drug: bivalirudin
* Drug: Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required. Exclusion Criteria: cardiogenic shock; thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; active or recent major bleeding or bleeding predisposition; major surgery within 1 month; clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; blood pressure higher than 180/110 mm Hg; known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min; history of heparin-induced thrombocytopenia; allergy to any of the study drugs or devices; pregnancy or lactation; any condition making PCI unsuitable or that might interfere with study adherence; and patient unwilling or unable to provide written informed consent.

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: heparin<br>For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines. | Drug: Heparin<br>* Heparin is used in patients undergoing percutaneous coronary intervention.<br>|
| Experimental: not prolong infusion Bivalirudin<br>Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure . | Drug: bivalirudin<br>* Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.<br>|
| Experimental: prolong infusion bivalirudin<br>Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure. | Drug: bivalirudin<br>* Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| creatine kinase-MB increase | creatine kinase-MB increase >3 times upper limit of normal | up to postprocedural 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding（BARC class） | including BARC class 2-5 | 30 days and 1 year | 
| major adverse cardiac or cerebral events | a composite of all cause death, reinfarction, target vessel revascularization or stroke | 30 days and 1 year | 
| Net Adverse Clinical Events | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding | 30 days and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bivalirudin, myocardial injure