Clinical trial NCT01585259: Anfibatide Phase Ib-IIa Clinical Trial
Official title: A Multi-center, Randomized, Double-blind, Multi-dose Group, Parallel Group and Placebo Controlled Phase Ib-IIa Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin for Injection for the Treatment of Patients With Non-ST Segment Elevation Myocardial Infarction (NSTEMI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-ST Segment Elevation Myocardial Infarction
Keywords: anti-platelet;
safety;
efficacy
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Platelet aggregation
timeFrame: up to 48 hours
measure: Bleeding events
timeFrame: Day 0 to day 30
Secondary outcomes:
measure: Mortality
timeFrame: 30 days after treatment
measure: Safety Endpoints
timeFrame: Day 0 to day 30
measure: Thrombosis formation
timeFrame: 48 hours after infusion during operation
measure: Thrombolysis in myocardial infraction (TIMI)
timeFrame: day 0
measure: Corrected TIMI frame count（CTFC）
timeFrame: day 0
measure: TIMI myocardial perfusion grade （TMBG）
timeFrame: day 0
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First hospiatl
Study officials:
References:
citation: Zheng B, Li J, Jiang J, Xiang D, Chen Y, Yu Z, Zeng H, Ge J, Dai X, Liu J, Li B, Huo Y. Safety and efficacy of a platelet glycoprotein Ib inhibitor for patients with non-ST segment elevation myocardial infarction: A phase Ib/IIa study. Pharmacotherapy. 2021 Oct;41(10):828-836. doi: 10.1002/phar.2620. Epub 2021 Sep 21.