Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

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.