Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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heparin

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

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

Heparin is used in patients undergoing percutaneous coronary intervention.

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 .

Group Type EXPERIMENTAL

bivalirudin

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

bivalirudin

Intervention Type DRUG

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

Interventions

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bivalirudin

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

Intervention Type DRUG

Heparin

Heparin is used in patients undergoing percutaneous coronary intervention.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No