Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
- Conditions
- ST Elevation Myocardial Infarction
- Interventions
- Registration Number
- NCT03822975
- Lead Sponsor
- Shenyang Northern Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6016
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Heparin unfractionated Heparin Heparin alone during primary PCI Bivalirudin Bivalirudin Bivalirudin with prolonged full dose infusion during primary PCI
- Primary Outcome Measures
Name Time Method Composite of all-cause death or BARC type 3~5 bleeding 30 days BARC=Bleeding academic research consortium
- Secondary Outcome Measures
Name Time Method BARC type 2-5 bleeding 30 days BARC=Bleeding academic research consortium
Stent thrombosis 30 days Definite or probable stent thrombosis according to Academic Research Consortium
Thrombocytopenia 30 days defined as platelet counts less than 150\*10\^9/L after treatment
All cause mortality 1 years BARC type 3-5 bleeding 30 days BARC=Bleeding academic research consortium
Major adverse cardiac and cerebral events (MACE) 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) 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 30 days BARC=Bleeding academic research consortium
Trial Locations
- Locations (85)
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, China
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