Anfibatide Treatment in STEMI Patients
Overview
A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Full Title of Study: “A Multi-centered, Randomized, Double-blinded, Placebo-Parallel Controlled Phase IIb Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin Injection for the Treatment of Patients With ST Segment Elevation Myocardial Infarction (STEMI) Before Receiving PCI Therapy.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: March 2016
Detailed Description
Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Interventions
- Drug: placebo
- Freeze-dried powder without snake venom will be dissovled in saline
- Drug: Anfibatide
- Freeze-dried powder with snake venom will be dissovled in saline
Arms, Groups and Cohorts
- Placebo Comparator: control
- 5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours
- Active Comparator: treatment
- 5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours
Clinical Trial Outcome Measures
Primary Measures
- ratio of TMPG grade 2 and grade 3
- Time Frame: within 24 hours
- After PCI, TMPG grade will be evaluated and
Secondary Measures
- inhibition rate of platelet aggregation and GP1b receptor combination rate
- Time Frame: 48 hours
- Baseline, 15-20 minutes after injection, 24-26 hours after injection, 48-50 hours after injection, 8-10 hours after the cease of medication, the comment and analysis of the inhibition rate of platelet aggregation and GP1b receptor combination rate
- Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy
- Time Frame: 24 hours
- Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy
- Time Frame: 24 hours
- The depression level of ST segment from right after the PCI therapy to 2 hours later
- Time Frame: within 24 hours
- i. Complete: depression level ≥ 70% ii. Partially: 30% ≤ depression level < 70% iii. None: < 30%
- Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively
- Time Frame: 72 hours
- (6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)
- Time Frame: 5 days
- (7) While surgery and hospitalization, follow the ratio and dose as suggested by the surgeon in case of emergency use of GP IIb/IIIa receptor antagonist or other antiplatelet drug
- Time Frame: 5 days
- (8) Clinical endpoint 30 days after surgery (caused by death, non-fatal myocardial infarction reissue, blood clot formation after stent implantation, non-fatal stroke, target lesion revascularization reissue) and the analysis of the causes
- Time Frame: 30days
- Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)
- Time Frame: 30days
Participating in This Clinical Trial
Inclusion Criteria
1. Aged 18-75 years; 2. Fulfill the standard of direct PCI: ST Segment Elevation Myocardial Infarction occurred < 12 hours (ST Segment Elevation or New Left Bundle Branch Block (LBBB), combined myocardial ischemia chest pain medical history or the dynamic change of cardiac marker (troponin and/or CK-MB); 3. Patients who will receive PCI and suitable for angioplasty and stent placement; 4. Patients, or their family or guardian give signed informed consent forms. Exclusion Criteria:
1. Patients with weight < 50kg; 2. Patients with severe hepatic or renal dysfunction, alanine aminotransferase (ALT) exceeds 3 times the normal maximum reference level, creatinine clearance level < 30ml/min or serum creatinine ≥ 200μmol/L or ≥2.5mg/dl; 3. Patients with severe hemodynamic instability; 4. Patients who will receive 2 times or more PCI treatment; 5. Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock; 6. Patients with untreated hypertension (SBP > 180mmHg or DBP > 110mmHg) or hypotension shock (SBP < 90mmHg); 7. Patients received GPIIb/IIIa receptor antagonists and/or thrombolytic therapy before randomization; 1. Used eptifibatide and tirofiban in the past 12 hours before the randomization; 2. Used abxicimab in the past 7 days before the randomization; 3. Have received thrombolytic therapy before the randomization; 8. Patients who need a long-term treatment of clopidogrel; 9. Patients who have received enoxaparin sodium injection before the surgery; 10. Patients who have hemorrhage risk: 1. Suffered from ischemic stroke or transient ischemic attack (TIA) in the past 12 months; 2. Suffered from hemorrhage stroke, or other life-long neuronal dysfunction; 3. Suffered from tumor, arteriovenous malformation in brain and aneurysms; 4. Suffered from traumatic brain injury in the past 3 months, or received major surgery; 5. Received percutaneous coronary intervention (PCI) in the past 6 months; 6. Have received coronary artery bypass graft therapy (CABG); 7. Receiving long-term oral anticoagulants therapy; 8. Suffered from active peptic ulcer, urinary and reproductive tract hemorrhage, or other active hemorrhage. 11. Patients with coagulation disorder: 1. Known as international normalized ratio > 2*; 2. Patients with coagulation abnormalities or other hemorrhagic tendency (including inherited hemorrhagic diseases, e.g. Von Willebrand disease or hemophilia; acquired hemorrhagic diseases; and other clinically identified hemorrhagic diseases with unsolved rationale); 3. Hematology test shows platelet count < 100x109mm3/L, or hemoglobin < 100g/L; 4. Recorded clopidogrel-related thrombocytopenia or agranulocytosis; 12. Life expectancy < 1 year; 13. Patients who have implemented with pacemaker, and contraindicated to MRI examination; 14. Patients who are allergic constitution or allergic to any component of aspirin, clopidogrel, creatinine, antiplatelet thrombolysin and investigational product; 15. Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures; 16. Patients who are participating or will be participating in other clinical trials; 17. Patients who have participated in clinical trials of antiplatelet thrombolysin or other related trials; 18. Patients who are not suitable for participating in this clinical trial according to the investigator's judgment, including who are unable or unwilling to follow the protocol; 19. Patients who participated in other clinical trials in the past 3 months.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Lee’s Pharmaceutical Limited
- Provider of Information About this Clinical Study
- Sponsor
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