Anfibatide Phase Ib-IIa Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Lee's Pharmaceutical Limited
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01585259
First received: April 24, 2012
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Non-ST Segment Elevation Myocardial Infarction
Drug: Anfibatide
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • Thrombosis formation [ Time Frame: 48 hours after infusion during operation ] [ Designated as safety issue: Yes ]

    Thrombosis formation after stent implantation:

    Definitive; Possible; Acute (≤24h); Subacute (>24h-30days)



Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]
    all-cause mortality, relapse of nonfatal myocardial infarction, nonfatal stroke, second target vascular reconstructio

  • Safety endpoints [ Time Frame: Day 0 to day 30 ] [ Designated as safety issue: Yes ]
    Bleeding events according to Bleeding Academic Research Consortium (BARC) definition

  • Safety Endpoints [ Time Frame: Day 0 to day 30 ] [ Designated as safety issue: Yes ]
    Degree of thrombocytopenia; Moderate (<100,000 platelets/mm3); Severe (<50,000 platelets/mm3); Extremely severe (<20,000 platelets/mm3)


Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anfibatide
Bolus injection will be finished in 5 minutes immediately when the guidewire passes through the first stenosed vessel; bolus injection of different doses+0.002IU/kg/h intravenous infusion for 48h
Drug: Anfibatide
Snake venom
Placebo Comparator: Placebo
Bolus injection will be finished in 5 minutes immediately when the guidewire passes through the first stenosed vessel; bolus injection of different doses+0.002IU/kg/h intravenous infusion for 48h
Drug: Placebo
Saline

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585259

Contacts
Contact: Yong Huo, M.D. Ph.D. +86-10-83572211

Locations
China
Peking University First hospiatl Recruiting
Beijing, China, 100000
Contact: Yong Huo, M.D. Ph. D.    +86-10-83572211      
Sponsors and Collaborators
Lee's Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01585259     History of Changes
Other Study ID Numbers: Lees_Anfibatide_Phase2
Study First Received: April 24, 2012
Last Updated: October 14, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Lee's Pharmaceutical Limited:
anti-platelet;
safety;
efficacy

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on October 19, 2014