Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

May 31, 2016 updated by: Yun Dai Chen, Chinese PLA General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1770

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 1000853
        • ChinaPLAGH
      • Beijing, Beijing, China, 100853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
creatine kinase-MB increase
Time Frame: up to postprocedural 72 hours
creatine kinase-MB increase >3 times upper limit of normal
up to postprocedural 72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinaPLA general hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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