Safety and Efficacy of Prolonged Use of Bivalirudin 4 Hours After ePCI (COBER Study)
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

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, 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.
    

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.
    

Intervention name(s): prolonged continuous use of bivalirudin; bivalirudin use during ePCI
Intervention type(s): Drug; Drug
Intervention description(s): prolonged continuous use of bivalirudin 4 hours after elective PCI (dose: 0.75 mg/kg bolus plus 1.75 mg/kg per hour); bivalirudin use during ePCI (0.75 mg/kg bolus plus 1.75 mg/kg per hour)
Other intervention name(s): prolonged continuous use of bivalirudin 4 hours after elective PCI; bivalirudin use during ePCI period
Intervention MeSH terms: Hirudins; Bivalirudin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: bivalirudin; prolonged use; peri-operative myocardial injury; percutaneous coronary intervention