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Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787317
Recruitment Status : Unknown
Verified May 2016 by Yun Dai Chen, Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Yun Dai Chen, Chinese PLA General Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. creatine kinase-MB increase [ Time Frame: up to postprocedural 72 hours ]
    creatine kinase-MB increase >3 times upper limit of normal


Secondary Outcome Measures :
  1. bleeding(BARC class) [ Time Frame: 30 days and 1 year ]
    including BARC class 2-5

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787317


Contacts
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Contact: Yundai chen, doctor +08613581886786 dingyutinkle@163.com

Locations
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China, Beijing
ChinaPLAGH
Beijing, Beijing, China, 1000853
ChinaPLAGH
Beijing, Beijing, China, 100853
Contact: yundai chen    08601055499309    dingyutinkle@163.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Publications of Results:
Other Publications:
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Responsible Party: Yun Dai Chen, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02787317    
Other Study ID Numbers: ChinaPLA general hospital
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yun Dai Chen, Chinese PLA General Hospital:
bivalirudin
myocardial injure
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Heparin
Bivalirudin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors