Last updated: July 11, 2021
Sponsor: Lee's Pharmaceutical Limited
Overall Status: Completed
Phase
1/2
Condition
Coronary Artery Disease
Myocardial Ischemia
Congestive Heart Failure
Treatment
N/AClinical Study ID
NCT01585259
Lees_Anfibatide_Phase2
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18-70 years;
- Laboratory tests show increase of the markers of myocardial damage (CK-MB,CTnI), orreduction after increase, with at least one values exceeding the 99th percentile ofthe upper limit of the reference value;
- Ischemia symptoms (ischemic chest pain lasts for over 15 minutes, little release aftertaking nitroglycerin sublingually) or a new myocardial ischemia onelectrocardiogram(ECG), i.e. a new ST-T variation (a new or transient depression of STsegment 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
Exclusion Criteria:
- Patients with severe unstable hemodynamics who should receive urgent PCI;
- Patients with untreated hypertension (SBP>180 mmHg or DBP >110mmHg) and hypotensionshock (SBP<90mmHg/80mmHg for over 30min);
- Investigator considers patients need to use GPIIb/IIIa receptor antagonists during thestudy period;
- After coronary angiography, the number of stenosed vessels >2;lesions in left mainbranch, severe calcification and artery graft lesions;
- Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiacshock;
- 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 aspartatetransaminase(AST) and alanine transaminase (ALT) exceeding 1.5 times the upper limitof 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) inthe 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 takeefficient 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'sjudgement.
Study Design
Total Participants: 90
Study Start date:
July 01, 2012
Estimated Completion Date:
July 31, 2015
Study Description
Connect with a study center
Peking University First hospiatl
Beijing, 100000
ChinaSite Not Available

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