Anfibatide Treatment in STEMI Patients

ST Segment Elevation Myocardial Infarction Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02495012
• Other study ID #: LeesPahrm_Anfibatide_Phase2b
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 8, 2015
• Last updated: July 10, 2015
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2015
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Drug:
• placebo
Freeze-dried powder without snake venom will be dissovled in saline
• Anfibatide
Freeze-dried powder with snake venom will be dissovled in saline

Locations

Country	Name	City	State
China	Peking University First hospiatl	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ratio of TMPG grade 2 and grade 3	After PCI, TMPG grade will be evaluated and	within 24 hours	No
Secondary	inhibition rate of platelet aggregation and GP1b receptor combination rate	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	48 hours	No
Secondary	Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy		24 hours	No
Secondary	Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy		24 hours	No
Secondary	The depression level of ST segment from right after the PCI therapy to 2 hours later	i. Complete: depression level = 70% ii. Partially: 30% = depression level < 70% iii. None: < 30%	within 24 hours	No
Secondary	Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively		72 hours	No
Secondary	(6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)		5 days	No
Secondary	(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		5 days	No
Secondary	(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		30days	Yes
Secondary	Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)		30days	Yes