Anfibatide Phase Ib-IIa Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01585259
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : June 3, 2016
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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).
Study Start Date : July 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Thrombosis formation [ Time Frame: 48 hours after infusion during operation ]

    Thrombosis formation after stent implantation:

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

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days after treatment ]
    all-cause mortality, relapse of nonfatal myocardial infarction, nonfatal stroke, second target vascular reconstructio

  2. Safety endpoints [ Time Frame: Day 0 to day 30 ]
    Bleeding events according to Bleeding Academic Research Consortium (BARC) definition

  3. Safety Endpoints [ Time Frame: Day 0 to day 30 ]
    Degree of thrombocytopenia; Moderate (<100,000 platelets/mm3); Severe (<50,000 platelets/mm3); Extremely severe (<20,000 platelets/mm3)

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01585259

Peking University First hospiatl
Beijing, China, 100000
Sponsors and Collaborators
Lee's Pharmaceutical Limited

Responsible Party: Lee's Pharmaceutical Limited Identifier: NCT01585259     History of Changes
Other Study ID Numbers: Lees_Anfibatide_Phase2
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: July 2015

Keywords provided by Lee's Pharmaceutical Limited:

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