Status
Completed
Phase
Not applicable
Enrollment
6,016
Locations
85
Results
Not posted
Publications
4
Study summary
This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.
Interventions
DRUG
Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is \>225 seconds.
DRUG
Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT \<225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is \>225 seconds.
Timeline
First posted
Jan 30, 2019
Study start
Feb 14, 2019
Primary completion
May 7, 2022
Study completion
May 6, 2023
Results posted
Not reported
Registry updated
Aug 27, 2025
Outcomes
Composite of all-cause death or BARC type 3~5 bleeding
Time frame · 30 days
BARC=Bleeding academic research consortium
All cause mortality
Time frame · 30 days
BARC type 3-5 bleeding
Time frame · 30 days
BARC=Bleeding academic research consortium
Major adverse cardiac and cerebral events (MACE)
Time frame · 30 days
MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
Net adverse clinical events (NACE)
Time frame · 30 days
NACE is defined as a composite of MACE or BARC type 3-5 bleeding
Composite of all-cause death or BARC type 2-5 bleeding
Time frame · 30 days
BARC=Bleeding academic research consortium
BARC type 2-5 bleeding
Time frame · 30 days
BARC=Bleeding academic research consortium
Stent thrombosis
Time frame · 30 days
Definite or probable stent thrombosis according to Academic Research Consortium
Thrombocytopenia
Time frame · 30 days
defined as platelet counts less than 150\*10\^9/L after treatment
All cause mortality
Time frame · 1 years
Eligibility
Inclusion Criteria: * Any age; * STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h; * Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin); * Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor); * The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent. Exclusion Criteria: * Not suitable for emergency primary PCI; * STEMI treated by thrombolysis; * Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI; * Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.); * Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor * Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Bengbu Second People's Hospital
Bengbu, Anhui, China
Fu Yang People'S Hospital
Fuyang, Anhui, China
Linquan County Peoples Hospital
Fuyang, Anhui, China
NO.2 People's Hospital of Fuyang City
Fuyang, Anhui, China
Taihe County People'S Hospital
Fuyang, Anhui, China
Bozhou Peoples Hospital
Haozhou, Anhui, China
Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science & Technology
Huainan, Anhui, China
The First Hospital of Anhui University of Science&Technology
Huainan, Anhui, China
Suzhou Municipal Hospital
Suzhou, Anhui, China
Beijing Luhe Hospital.Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital Yanqing Hospital
Beijing, Beijing Municipality, China
Chongqing University Fuling Hospital
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Meizhou Peopie's Hospital
Meizhou, Guangdong, China
Yulin First People's Hospital
Yulin, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital Ofzunyi Medical University
Zunyi, Guizhou, China
Hengshuicardiovascularhospital
Hengshui, Hebei, China
Jiaozuo People's Hospital
Jiaozuo, Henan, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Luohe Central Hospital
Luohe, Henan, China
The First People'S Hospital of Ruzhou
Ruzhou, Henan, China
Shangqiu first people's Hospital
Shangqiu, Henan, China
The Third Affiliated Hospital Of Xinxiang Medical University
Xinxiang, Henan, China
Publications
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