Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02787317

Collaborator

(none)

1,770

Enrollment

Locations

Arms

Duration (Months)

885

Patients Per Site

29.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Drug: bivalirudin Drug: Heparin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1770 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: heparin

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

Drug: Heparin

Heparin is used in patients undergoing percutaneous coronary intervention.

Experimental: not prolong infusion Bivalirudin

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

Drug: bivalirudin

Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.

Experimental: prolong infusion 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.

Drug: bivalirudin

Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.

Outcome Measures

Primary Outcome Measures

creatine kinase-MB increase [up to postprocedural 72 hours]
creatine kinase-MB increase >3 times upper limit of normal

Secondary Outcome Measures

bleeding（BARC class） [30 days and 1 year]
including BARC class 2-5
major adverse cardiac or cerebral events [30 days and 1 year]
a composite of all cause death, reinfarction, target vessel revascularization or stroke
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.