Anfibatide Phase Ib-IIa Clinical Trial

• This study is a phase Ib-IIa exploratory study to observe the safety of Antiplatelet Thrombolysin for Injection for the treatment of non-ST segment myocardial infarction (NSTEMI) patients and preliminarily evaluate the efficacy of different doses, providing the theoretical basis of the phase II and III clinical study protocol.
• To investigate the pharmacokinetics of different doses.

Inclusion criteria

• Aged 18-70 years;
• 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;
• 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);
• Patients receive PCI after coronary angiography;
• Patients, or their family or guardian give signed informed consent forms.

Exclusion criteria

• Patients with severe unstable hemodynamics who should receive urgent PCI;
• Patients with untreated hypertension (SBP>180 mmHg or DBP >110mmHg) and hypotension shock (SBP<90mmHg/80mmHg for over 30min);
• Investigator considers patients need to use GPIIb/IIIa receptor antagonists during the study period;
• After coronary angiography, the number of stenosed vessels >2；lesions in left main branch, severe calcification and artery graft lesions;
• Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
• Patients with malignant arrhythmia, e.g. the third-degree atrioventricular block, ventricular tachycardia or fibrillation ventricular;
• 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;
• Patients who have received PCI in the past six months;
• Patients who have received coronary artery bypass grafting (CABG) previously;
• Patients who have received invasive operation in the past 3 months;
• 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;
• Patients who need a long-term treatment of oral anticoagulants (such as warfarin);
• Patients with active peptic ulcer, or other diseases of hemorrhagic tendency;
• Patients with disease of coagulation disorder;
• Hematology test shows platelet count <100,000mm3,or hemoglobin<100g/L;
• Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures;
• Patients with an allergic constitution;
• Patients who is participating in other clinical trials;
• Patients who do not give a signed informed consent forms;
• Patients who are not suitable to enroll in the trial according to the investigator's judgement.