Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Coronary Disease

Treatments: Drug: bivalirudin; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02787317

ChinaPLA general hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,770 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,770 participants in 3 patient groups

heparin

Active Comparator group

Description:

For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines.

Treatment:

Drug: Heparin

not prolong infusion Bivalirudin

Experimental group

Description:

Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure .

Treatment:

Drug: bivalirudin

prolong infusion bivalirudin

Experimental group

Description:

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.

Treatment:

Drug: bivalirudin