Safety and Efficacy of Prolonged Use of Bivalirudin 4 Hours After ePCI (COBER Study)

August 8, 2022 updated by: Nanjing First Hospital, Nanjing Medical University

Safety and Efficacy of Prolonged Use of Bivalirudin 4 Hours After Elective PCI in Patients With CHD (COBER Study)

Since the development of percutaneous coronary intervention (PCI) in patients with coronary heart disease (CHD), unfractionated heparin (UFH) and low molecular weight heparin (LWMH) have been the preferred anticoagulants in peri-operative period. However, UFH has some defects, such as incomplete and unstable inhibition of thrombin, large individual differences, multiple monitoring of activated coagulation time (ACT), ineffective thrombin binding to fibrin, non-specific protein binding and induced thrombocytopenia (HIT). Compared with UFH, LWMH has lower non-specific protein binding rate, but it is not superior to UFH in efficacy, hemorrhage and HIT.

Bivalirudin can bind specifically to thrombin catalytic site and anionic external binding site, directly inhibit thrombin activity, thereby inhibiting thrombin-catalyzed and induced reactions. At the same time, thrombin can also inactivate it by enzymatic hydrolysis of bivalirudin. Therefore, the inhibition of bivalirudin on thrombin is reversible and transient, and the risk of bleeding after drug withdrawal is relative small. It has been reported that bivalirudin can significantly reduce the risk of peri-operative bleeding during PCI period compared with UFH. Clopidogrel had not yet played a role in most patients after emergency PCI, and there was a "blank period" for 2-4 hours without effective antithrombotic concentration, which was also the peak period of acute stent thrombosis. Han and coworkers have shown that for acute myocardial infarction (AMI) patients undergoing emergency PCI, whether or not glycoprotein IIb/IIIa inhibitors were added, prolonged peri-operative use of bivalrudin was significantly better than UFH in terms of net clinical adverse event. However, for patients with elective PCI (ePCI), prolonged bivalirudin use was only used in some patients in REPLACE-2 and ISAR-REACT-3 studies, and the prolonged time of bivalrudin use after ePCI was not definite.

Therefore, in the current study we aim to explore the efficacy and safety of prolonged bivalirudin use 4 hours after elective PCI in patients with CHD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current study is designed as a single-center, randomized and prospective study aiming to evaluate the safety and efficacy of prolonged continuous use of bivalirudin 4 hours after ePCI for the treatment of peri-operative myocardial injury (PMI) compared with the bivalirudin use during ePCI. Based on previous study reported and estimated 10% loss follow-up of these patients in each arm, a total of 330 patients with CHD were required in our study, and with 165 patients per group as a ratio of 1:1 randomization.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital, Nanjing Medical University

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 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • De novo lesions
  • elective PCI
  • Only single coronary artery treated at this time

Exclusion Criteria:

  • Those who meet the diagnostic criteria of acute myocardial infarction
  • Patients with cardio-genic shock
  • Patients with multiple organ failure
  • Patients allergic to contrast
  • Patients who can not tolerate dual antiplatelet therapy
  • Patients who can't tolerate anticoagulation
  • Recently infected patients
  • Patients with hepatorenal dysfunction
  • Thrombotic lesion of coronary artery
  • Chronic total coronary occlusion lesion
  • Patients with complex coronary bifurcation requiring two stent strategy
  • Severe coronary calcified lesion
  • Patients with percutaneous coronary angioplasty
  • Patients with directional coronary atherectomy or rotational atherectomy
  • Patients with drug coated balloon treatment
  • Patients with bioabsorbable vascular scaffold implantation
  • Previous percutaneous coronary intervention
  • Previous coronary artery bypass graft
  • Patients with active stage of autoimmune disease

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: prolonged continuous use of bivalirudine
A total of 165 patients are assigned to group with prolonged continuous use of bivalirudin after randomization schedule.
Drug: prolonged continuous use of bivalirudin
prolonged continuous use of bivalirudin 4 hours after elective PCI (dose: 0.75 mg/kg bolus plus 1.75 mg/kg per hour)
Other Names:
  • prolonged continuous use of bivalirudin 4 hours after elective PCI
OTHER: bivalirudin use during ePCI
A total of 165 patients are assigned to group with bivalirudin use during ePCI after randomization schedule.
Drug: bivalirudin use during ePCI
bivalirudin use during ePCI (0.75 mg/kg bolus plus 1.75 mg/kg per hour)
Other Names:
  • bivalirudin use during ePCI period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of PMI in CHD patients 3 days after ePCI
Time Frame: Clinical follow up at 3 days after ePCI
the incidence rate of PMI indicated by the changes of myocardial injury biomarkers (such as TNI and CK-MB) in CHD patients between prolonged use of bivalirudin and bivalirudin use during ePCI groups
Clinical follow up at 3 days after ePCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of MACEs and bleeding
Time Frame: Clinical follow up at 7 days after ePCI
The incidence rate of major adverse cardiac events and bleeding between prolonged use of bivalirudin and bivalirudin use during ePCI groups
Clinical follow up at 7 days after ePCI

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Zhiming Wu, MD, Nanjing First Hospital, Nanjing Medical University

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 (ACTUAL)

September 20, 2019

Primary Completion (ACTUAL)

August 1, 2022

Study Completion (ACTUAL)

August 1, 2022

Study Registration Dates

First Submitted

September 29, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (ACTUAL)

October 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20190823-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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