Anfibatide Treatment in STEMI Patients

NCT02495012 | Unknown Phase 2 DMC

• 1 other identifier: LeesPahrm_Anfibatide_Phase2b
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

efficacy; safety; STEMI

Outcome Measures

Primary Outcomes (1)

• ratio of TMPG grade 2 and grade 3

  After PCI, TMPG grade will be evaluated and

  within 24 hours

Secondary Outcomes (9)

• inhibition rate of platelet aggregation and GP1b receptor combination rate

  48 hours

• Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy

  24 hours

• Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy

  24 hours

• The depression level of ST segment from right after the PCI therapy to 2 hours later

  within 24 hours

• 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

Study Arms (2)

control

PLACEBO COMPARATOR

5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours

Drug: placebo

treatment

ACTIVE COMPARATOR

5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours

Drug: Anfibatide

Interventions

placebo DRUG

Freeze-dried powder without snake venom will be dissovled in saline

control

Anfibatide DRUG

Freeze-dried powder with snake venom will be dissovled in saline

treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years;
• 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);
• Patients who will receive PCI and suitable for angioplasty and stent placement;
• Patients, or their family or guardian give signed informed consent forms.

You may not qualify if:

• Patients with weight \< 50kg;
• 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;
• Patients with severe hemodynamic instability;
• Patients who will receive 2 times or more PCI treatment;
• Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
• Patients with untreated hypertension (SBP \> 180mmHg or DBP \> 110mmHg) or hypotension shock (SBP \< 90mmHg);
• Patients received GPIIb/IIIa receptor antagonists and/or thrombolytic therapy before randomization;
• Used eptifibatide and tirofiban in the past 12 hours before the randomization;
• Used abxicimab in the past 7 days before the randomization;
• Have received thrombolytic therapy before the randomization;
• Patients who need a long-term treatment of clopidogrel;
• Patients who have received enoxaparin sodium injection before the surgery;
• Patients who have hemorrhage risk:
• Suffered from ischemic stroke or transient ischemic attack (TIA) in the past 12 months;
• Suffered from hemorrhage stroke, or other life-long neuronal dysfunction;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Peking University First hospiatl

Beijing, 100000, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

agkisacucetin protein, Agkistrodon acutus

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 13, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

CN (1)