Acute Myocardial Infarction, Percutaneous Coronary Intervention
Conditions
Keywords
Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty
Brief summary
The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
Detailed description
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
Interventions
DRUGBivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
DRUGheparin
heparin monotherapy
DRUGheparin plus tirofiban
combined use of heparin and tirofiban during PCI
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 years old 2. Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset within 12h for STEMI (or within 24 h for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI 3. Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure. 4. Provide written informed consent.
Exclusion criteria
1. Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock. 2. Any anticoagulant agents were used 48 h before randomization. 3. Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.; 4. Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.), 5. Deep puncture or major surgery (including eye or brain surgery) within 1 month. 6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. 7. Untreated or uncontrolled hypertension \> 180/110 mmHg. 8. Hemoglobin \< 100 g/L or platelet count \< 100 \* 109 / L. 9. Elevated AST, ALT level higher than three times of the normal upper limit. 10. severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2). 11. Heparin induced thrombocytopenia. 12. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. 13. Pregnancy or lactation. 14. Researchers think that doesn't fit to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical Events | 30 days | A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical events | 1 year | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings |
| any bleedings (BARC class) | 30 day | including all BARC class (class 1-5) |
| Major adverse cardiac and cerebral events (MACCE) | 30 days and 1 year | a composite of all cause death, reinfarction, target vessel revascularization or stroke |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thrombocytopenia | 30 days | Defined as a decrease of platelet count of more than 50% or more than 150000 platelet/mm3 compared with baseline within 24h after study drug administration |
| stent thrombosis | 30 days and 1 year | by ARC definition |
Countries
China
Outcome results
None listed