Anfibatide Phase Ib-IIa Clinical Trial

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/A

Clinical Study ID

NCT01585259
Lees_Anfibatide_Phase2
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-70 years;
  2. 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;
  3. 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);
  4. Patients receive PCI after coronary angiography;
  5. Patients, or their family or guardian give signed informed consent forms.

Exclusion

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 hypotensionshock (SBP<90mmHg/80mmHg for over 30min);
  3. Investigator considers patients need to use GPIIb/IIIa receptor antagonists during thestudy period;
  4. After coronary angiography, the number of stenosed vessels >2;lesions in left mainbranch, severe calcification and artery graft lesions;
  5. Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiacshock;
  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 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;
  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) inthe 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 takeefficient 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'sjudgement.

Study Design

Total Participants: 90
Study Start date:
July 01, 2012
Estimated Completion Date:
July 31, 2015

Study Description

  1. 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.

  2. To investigate the pharmacokinetics of different doses.

Connect with a study center

  • Peking University First hospiatl

    Beijing, 100000
    China

    Site Not Available

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