acute coronary syndrome
Conditions
Interventions
Standard regimen group:Bivalirudin infusion at standard regimen
Low regimen group:Bivalirudin infusion at low (standard of 80 percent) regimen
Sponsors
The PLA Northern Theater Command General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18; 2. Acute coronary syndrome patients with planed elective PCI; 3. Patient is able to tolerate dual antiplatelet therapy for more than 6 months and meet any one or more of the following criteria (1) Age >= 65 (2) Hemoglobin= 3.0 (5) Female patient with acute coronary system (6) Body mass index<18.5Kg/m^2 (7) Congestive heart failure and LVEF from 0.30 to 0.40 (8) Thrombocytopenia (platelet count<100 x 10^9/L) (9) History of heparin induced thrombocytopenia (10) History of bleeding (gastrointestinal hemorrhage, fundus hemorrhage, intracranial hemorrhage) before 6 months (11) Plan to take NSAIDs or steroids for more than 30 days after PCI (12) Chronic liver disease 4. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. STEMI within 7 days after symptom onset 2. NSTEMI underwent emergency primary PCI 3. Mechanical complications after myocardial infarction 4. Ventricular aneurysm larger than 3.0 x 2.0cm or intracardiac thrombus within 30 days by echocardiography 5. Hemodynamic instability (KILLIP >= 3 class) 6. Severe arrhythmia 7. LVEF3x the upper limit of normal 13. Have received oral anticoagulants (e.g., rivaroxiban, warfarin, etc.) within 2 weeks 14. Have received anticoagulants (e.g., heparin, low molecular weight heparin, fondaparinux, bivalirudin, etc.) or antiplatelet injections (tirofiban) within 48h before PCI 15. Known history of bivalirudin, contrast, aspirin, clopidogrel, or ticagrelor allergy or Contraindications 16. Pregnancy 17. No willingness to receive PCI or poor adherence to clinical trial 18. Severe progressive disease, and anticipated life expectancy<6 months 19. Other contraindications of PCI 20. Unable to obtain an informed consent or the researchers thinks it is not suitable to participate in this trial in any case 21. Participating in other ongoing clinical studies and has not completed the follow-up to the primary endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net adverse clinical events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events; | — |
Countries
China
Contacts
Public ContactWang Xiaozeng
The PLA Northern Theater Command General Hospital
Outcome results
None listed