Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Phase 4

• Conditions: Coronary Disease
• Interventions: Drug: bivalirudin; Drug: Heparin

• Registration Number: NCT02787317
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-31
• Last Update Submitted: 2016-05-31
• Study First Posted: 2016-06-01
• Last Update Posted: 2016-06-01
• Primary Completion: 2017-10
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1770

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prolong infusion bivalirudin	bivalirudin	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.
heparin	Heparin	For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines.
not prolong infusion Bivalirudin	bivalirudin	Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure .

Primary Outcome Measures

Name	Time	Method
creatine kinase-MB increase	up to postprocedural 72 hours	creatine kinase-MB increase \>3 times upper limit of normal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ChinaPLAGH; 🇨🇳 Beijing, Beijing, China