Coronary Artery Disease
Conditions
Interventions
B:argatroban
Sponsors
The Cardiovascular department, the General Hospital of PLA, No.28 Fuxing Road, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree to attend clinical trial and sign written informed consent; 2. Male or female (women of child bearing potential must have a negative pregnancy test prior to entry into the study) age between 18 and 75 years old; 3. Diagnosis of stable coronary artery disease (CAD) or unstable angina according to the ACC/AHA with moderate to high bleeding risk and a requirement for elective percutaneous coronary angioplasty or stent insertion with an approved device in one or more de novo-treated or re-stenotic lesions in native vessels.
Exclusion criteria
Exclusion criteria: 1. Any condition which, in the investigator's opinion, contraindicates the use of argatroban, heparin, aspirin, clopidogrel or endangers the patient if he/she participated in this study; 2. Known cirrhosis, hepatitis, clinically significant hepatic disorder, or history of hepatic disorder. Hepatic disorder is defined as having levels of liver function tests (total bilirubin, AST, ALT greater than 2.0 times above the upper limit of the normal range of local laboratory; 3. Severe agranulocytosis and platelet count less than <100*10^9/L; 4. Uncontrolled hypertension defined as greater than 180/120 mmHg (1mmHg=0.133kPa); 5. Use of heparin during 48h prior to study or low molecular heparin (LMWH) during 24 h prior to PCI; 6. Receive thrombolysis treatment during 48h prior to study; 7. myocardial infarction within the past 1 week; 8. Lumbar puncture within the past the past 2 weeks; 9. Current use of warfarin; 10. History of bleeding diathesis, coagulopathy or severe peripheral vascular disease; 11. APTT equal or greater than 90 sec without identified reason; 12. Pregnancy (exclusion by routine urine test) or lactating woman; 13. Active, uncontrolled peptic ulcer disease or any gastrointestinal bleeding or genitourinary bleeding within 3 months prior to study enrolment; 14. History of previous cerebral aneurysm, haemorrhagic stroke, or thrombotic stroke within the past 6 months; 15. Major surgery, serious trauma, puncture of non-compressible vessel, or biopsy of parenchymal organ within prior 2 months; 16. Severe arrhythmia(including ventricular fibrillation and sustained artery fibrillation); 17. Presence of greater than 50% stenosis of unprotected left main coronary artery; 18. Permanent or temporary pacemaker; 19. Participation in other clinical trials; 20. Terminally ill patients with a life expectancy of < 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Activation hemoglutination time; | — |
Countries
China
Contacts
Public ContactYundai Chen
Outcome results
None listed