Safety and Efficacy of Delayed Continuous Use of Bivalirudin 4 Hours After ePCI (COBER Study)
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|ClinicalTrials.gov Identifier: NCT04120961|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
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
|Contact: Zhiming Wu, MD||+86 email@example.com|
|Contact: Xiangqi Wu, MD||+86 firstname.lastname@example.org|
|Nanjing First Hospital, Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210006|
|Contact: Jie Zhou +86 13913893984 email@example.com|
|Principal Investigator:||Zhiming Wu, MD||Nanjing First Hospital, Nanjing Medical University|