Anfibatide Phase Ib-IIa Clinical Trial

NCT01585259 | Completed Phase 1 DMC

• 1 other identifier: Lees_Anfibatide_Phase2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-ST Segment Elevation Myocardial Infarction

Keywords

anti-platelet;; safety;; efficacy

Outcome Measures

Primary Outcomes (2)

• Platelet aggregation

  The inhibition of ristocetin-induced platelet aggregation as measured by whole blood impedance aggregometr in vitro.

  up to 48 hours

• Bleeding events

  Bleeding events classified according to the Bleeding Academic Research Consortium (BARC) .

  Day 0 to day 30

Secondary Outcomes (6)

• Mortality

  30 days after treatment

• Safety Endpoints

  Day 0 to day 30

• Thrombosis formation

  48 hours after infusion during operation

• Thrombolysis in myocardial infraction (TIMI)

  day 0

• Corrected TIMI frame count（CTFC）

  day 0

Study Arms (2)

Anfibatide

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Anfibatide DRUG

Snake venom

Anfibatide

Placebo DRUG

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years;
• 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;
• 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);
• Patients receive PCI after coronary angiography;
• Patients, or their family or guardian give signed informed consent forms.

You may not qualify if:

• Patients with severe unstable hemodynamics who should receive urgent PCI;
• Patients with untreated hypertension (SBP\>180 mmHg or DBP \>110mmHg) and hypotension shock (SBP\<90mmHg/80mmHg for over 30min);
• Investigator considers patients need to use GPIIb/IIIa receptor antagonists during the study period;
• After coronary angiography, the number of stenosed vessels \>2；lesions in left main branch, severe calcification and artery graft lesions;
• Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
• Patients with malignant arrhythmia, e.g. the third-degree atrioventricular block, ventricular tachycardia or fibrillation ventricular;
• 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;
• Patients who have received PCI in the past six months;
• Patients who have received coronary artery bypass grafting (CABG) previously;
• Patients who have received invasive operation in the past 3 months;
• 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;
• Patients who need a long-term treatment of oral anticoagulants (such as warfarin);
• Patients with active peptic ulcer, or other diseases of hemorrhagic tendency;
• Patients with disease of coagulation disorder;
• Hematology test shows platelet count \<100,000mm3,or hemoglobin\<100g/L;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Peking University First hospiatl

Beijing, 100000, China

Location

Related Publications (1)

• Zheng B, Li J, Jiang J, Xiang D, Chen Y, Yu Z, Zeng H, Ge J, Dai X, Liu J, Li B, Huo Y. Safety and efficacy of a platelet glycoprotein Ib inhibitor for patients with non-ST segment elevation myocardial infarction: A phase Ib/IIa study. Pharmacotherapy. 2021 Oct;41(10):828-836. doi: 10.1002/phar.2620. Epub 2021 Sep 21.

  PMID: 34478577 DERIVED

MeSH Terms

Interventions

agkisacucetin protein, Agkistrodon acutus

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: July 14, 2021

Record last verified: 2015-07

Locations

CN (1)