Anfibatide Phase Ib-IIa Clinical Trial

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited

Criteria

Inclusion Criteria:

1. Aged 18-70 years;

2. Laboratory tests show increase of the markers of myocardial damage (CK-MB,CTnI), or reduction after increase, with at least one values exceeding the 99th percentile of the upper limit of the reference value;

3. Ischemia symptoms (ischemic chest pain lasts for over 15 minutes, little release after taking nitroglycerin sublingually) or a new myocardial ischemia on electrocardiogram(ECG), i.e. a new ST-T variation (a new or transient depression of ST segment by over 0.1mV, or T-wave inversion≥0.2mV);

4. Patients receive PCI after coronary angiography;

5. Patients, or their family or guardian give signed informed consent forms.

Exclusion Criteria:

1. Patients with severe unstable hemodynamics who should receive urgent PCI;

2. Patients with untreated hypertension (SBP>180 mmHg or DBP >110mmHg) and hypotension shock (SBP<90mmHg/80mmHg for over 30min);

3. Investigator considers patients need to use GPIIb/IIIa receptor antagonists during the study period;

4. After coronary angiography, the number of stenosed vessels >2；lesions in left main branch, severe calcification and artery graft lesions;

5. Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;

6. Patients with malignant arrhythmia, e.g. the third-degree atrioventricular block, ventricular tachycardia or fibrillation ventricular;

7. Patients with severe hepatic or renal dysfunction, with serum aspartate transaminase(AST) and alanine transaminase (ALT) exceeding 1.5 times the upper limit of reference values, creatinine clearance <30ml/min or serum creatinine ≥200μmol/L or 2.5mg/dl;

8. Patients who have received PCI in the past six months;

9. Patients who have received coronary artery bypass grafting (CABG) previously;

10. Patients who have received invasive operation in the past 3 months;

11. Patients who have suffered from ischemic stroke or transient ischemic attack (TIA) in the past 6 months, or patients with past history of hemorrhagic stroke;

12. Patients who need a long-term treatment of oral anticoagulants (such as warfarin);

13. Patients with active peptic ulcer, or other diseases of hemorrhagic tendency;

14. Patients with disease of coagulation disorder;

15. Hematology test shows platelet count <100,000mm3,or hemoglobin<100g/L;

16. Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures;

17. Patients with an allergic constitution;

18. Patients who is participating in other clinical trials;

19. Patients who do not give a signed informed consent forms;

20. Patients who are not suitable to enroll in the trial according to the investigator's judgement.