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NCT Number: NCT04120961

Safety and Efficacy of Prolonged Use of Bivalirudin 4 Hours After ePCI (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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prolonged continuous use of bivalirudin

Drug

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

bivalirudin use during ePCI

Drug

bivalirudin use during ePCI (0.75 mg/kg bolus plus 1.75 mg/kg per hour)

Other names: bivalirudin use during ePCI period

Primary outcomes

  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 prolonged use of bivalirudin and bivalirudin use during ePCI groups

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2019
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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