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Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Primary Purpose

Coronary Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

bivalirudin

Heparin

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring bivalirudin, myocardial injure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

ChinaPLAGH
ChinaPLAGH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

heparin

not prolong infusion Bivalirudin

prolong infusion bivalirudin

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

creatine kinase-MB increase

creatine kinase-MB increase >3 times upper limit of normal

Secondary Outcome Measures

bleeding（BARC class）

including BARC class 2-5

major adverse cardiac or cerebral events

a composite of all cause death, reinfarction, target vessel revascularization or stroke

Net Adverse Clinical Events

a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding

Full Information

NCT ID

NCT02787317

First Posted

May 24, 2016

Last Updated

May 31, 2016

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02787317

Brief Title

Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Official Title

Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

Keywords

bivalirudin, myocardial injure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1770 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

heparin

Arm Type

Active Comparator

Arm Description

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

Arm Title

not prolong infusion Bivalirudin

Arm Type

Experimental

Arm Description

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

Arm Title

prolong infusion bivalirudin

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

bivalirudin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Heparin

Intervention Description

Heparin is used in patients undergoing percutaneous coronary intervention.

Primary Outcome Measure Information:

Title

creatine kinase-MB increase

Description

creatine kinase-MB increase >3 times upper limit of normal

Time Frame

up to postprocedural 72 hours

Secondary Outcome Measure Information:

Title

bleeding（BARC class）

Description

including BARC class 2-5

Time Frame

30 days and 1 year

Title

major adverse cardiac or cerebral events

Description

a composite of all cause death, reinfarction, target vessel revascularization or stroke

Time Frame

30 days and 1 year

Title

Net Adverse Clinical Events

Description

a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding

Time Frame

30 days and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yundai chen, doctor

Phone

+08613581886786

dingyutinkle@163.com

Facility Information:

Facility Name

ChinaPLAGH

City

Beijing

State/Province

Beijing

ZIP/Postal Code

1000853

Country

China

Facility Name

ChinaPLAGH

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

yundai chen

Phone

08601055499309

dingyutinkle@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25775052

Citation

Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323.

Results Reference

background

PubMed Identifier

19801025

Citation

Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.

Results Reference

result

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Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

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