NCT02787317

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,770

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2016

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

May 24, 2016

Last Update Submit

May 31, 2016

Conditions

Coronary Disease

Keywords

bivalirudinmyocardial injure

Outcome Measures

Primary Outcomes (1)

  • creatine kinase-MB increase

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

    up to postprocedural 72 hours

Secondary Outcomes (3)

  • bleeding（BARC class）

    30 days and 1 year

  • major adverse cardiac or cerebral events

    30 days and 1 year

  • Net Adverse Clinical Events

    30 days and 1 year

Study Arms (3)

heparin

ACTIVE COMPARATOR

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

Drug: Heparin

not prolong infusion Bivalirudin

EXPERIMENTAL

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

Drug: bivalirudin

prolong infusion bivalirudin

EXPERIMENTAL

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

Interventions

bivalirudinDRUG

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

not prolong infusion Bivalirudinprolong infusion bivalirudin
HeparinDRUG

Heparin is used in patients undergoing percutaneous coronary intervention.

heparin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ChinaPLAGH

Beijing, Beijing Municipality, 1000853, China

Location

ChinaPLAGH

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (2)

  • 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.

    PMID: 25775052BACKGROUND

  • 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.

    PMID: 19801025RESULT

MeSH Terms

Conditions

Coronary Disease

Interventions

bivalirudinHeparin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Yundai chen, doctor

CONTACT

+08613581886786dingyutinkle@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chinese PLA General Hospital

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 1, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2018

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

CN(2)