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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120961
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

Brief Summary:

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, delayed peri-operative injection of bivalrudin was significantly better than UFH in terms of net clinical adverse event. However, for patients with elective PCI (ePCI), delayed bivalirudin injection was only used in some patients in REPLACE-2 and ISAR-REACT-3 studies, and the delayed time of bivalrudin use after ePCI was not definite.

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


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: delayed continuous use of bivalirudin Drug: bivalirudin use during ePCI Not Applicable

Detailed Description:
The current study is designed as a single-center, randomized and prospective study aiming to evaluate the safety and efficacy of delayed continuous use of bivalirudin 4 hours after ePCI for the treatment of peri-operative myocardial injury (PMI) compared with 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Delayed Continuous Use of Bivalirudin 4 Hours After Elective PCI in Patients With CHD (COBER Study)
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bivalirudin

Arm Intervention/treatment
Experimental: delayed continuous use of bivalirudine
A total of 165 patients are assigned to group with delayed continuous use of bivalirudin after randomization schedule.
Drug: delayed continuous use of bivalirudin
delayed continuous use of bivalirudin 4 hours after elective PCI (dose: 0.75 mg/kg bolus plus 1.75 mg/kg per hour)
Other Name: delayed continuous use of bivalirudin 4 hours after elective PCI

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 Name: bivalirudin use during ePCI period




Primary Outcome Measures :
  1. 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 delayed continuous use of bivalirudin and bivalirudin use during ePCI groups


Secondary Outcome Measures :
  1. The incidence rate of patient-related ischemic events and bleeding [ Time Frame: Clinical follow up at 30 days, 6, 9 and 12 months after the operation ]
    The incidence rate of patient-related ischemic events including all myocardial infarction , any revascularization and all-cause death, and bleeding between delayed continuous use of bivalirudin and bivalirudin use during ePCI groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective PCI
  • Preoperative score of CRUSADE > 30 or suspected or confirmed HIT patients

Exclusion Criteria:

  • PCI within 1 month
  • Complicated with blood or rheumatism and immune system diseases
  • Life expectancy no more than 1 year or factors causing difficulties in clinical follow up
  • A history of peptic ulcer or GI bleeding in the previously
  • Stroke within 6 months prior to the operation
  • A history of severe hepatic or renal failure

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): NCT04120961


Contacts
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Contact: Zhiming Wu, MD +86 18001599783 wuzhiming1997@126.com
Contact: Xiangqi Wu, MD +86 15250997876 15250997876@163.com

Locations
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China, Jiangsu
Nanjing First Hospital, Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Jie Zhou    +86 13913893984    565219791@qq.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Principal Investigator: Zhiming Wu, MD Nanjing First Hospital, Nanjing Medical University

Publications:

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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04120961    
Other Study ID Numbers: KY20190823-05
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
bivalirudin
delayed use
peri-operative myocardial injury
percutaneous coronary intervention
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
Hirudins
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents