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Anfibatide Phase Ib-IIa Clinical Trial

Primary Purpose

Non-ST Segment Elevation Myocardial Infarction

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Anfibatide

Placebo

About this trial

This is an interventional treatment trial for Non-ST Segment Elevation Myocardial Infarction focused on measuring anti-platelet;, safety;, efficacy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures;
Patients with an allergic constitution;
Patients who is participating in other clinical trials;
Patients who do not give a signed informed consent forms;
Patients who are not suitable to enroll in the trial according to the investigator's judgement.

Sites / Locations

Peking University First hospiatl

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anfibatide

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Platelet aggregation

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

Bleeding events

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

Secondary Outcome Measures

Mortality

all-cause mortality, relapse of nonfatal myocardial infarction, nonfatal stroke, second target vascular reconstructio.

Safety Endpoints

Degree of thrombocytopenia; Moderate (<100,000 platelets/mm3); Severe (<50,000 platelets/mm3); Extremely severe (<20,000 platelets/mm3)

Thrombosis formation

Thrombosis formation after stent implantation:

Thrombolysis in myocardial infraction (TIMI)

The proportion of TIMI from grade 0 to 3 Pre -and post-PCI was evaluated.

Corrected TIMI frame count（CTFC）

The values of CTFC were evaluated and compared between groups.

TIMI myocardial perfusion grade （TMBG）

The proportion of TMPG from grade 0 to 3 Pre -and post-PCI was evaluated.

Full Information

NCT ID

NCT01585259

First Posted

April 24, 2012

Last Updated

July 11, 2021

Sponsor

Lee's Pharmaceutical Limited

1. Study Identification

Unique Protocol Identification Number

NCT01585259

Brief Title

Anfibatide Phase Ib-IIa Clinical Trial

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 Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lee's Pharmaceutical Limited

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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. To investigate the pharmacokinetics of different doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-ST Segment Elevation Myocardial Infarction

Keywords

anti-platelet;, safety;, efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anfibatide

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Anfibatide

Intervention Description

Snake venom

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Saline

Primary Outcome Measure Information:

Title

Platelet aggregation

Description

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

Time Frame

up to 48 hours

Title

Bleeding events

Description

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

Time Frame

Day 0 to day 30

Secondary Outcome Measure Information:

Title

Mortality

Description

all-cause mortality, relapse of nonfatal myocardial infarction, nonfatal stroke, second target vascular reconstructio.

Time Frame

30 days after treatment

Title

Safety Endpoints

Description

Degree of thrombocytopenia; Moderate (<100,000 platelets/mm3); Severe (<50,000 platelets/mm3); Extremely severe (<20,000 platelets/mm3)

Time Frame

Day 0 to day 30

Title

Thrombosis formation

Description

Thrombosis formation after stent implantation:

Time Frame

48 hours after infusion during operation

Title

Thrombolysis in myocardial infraction (TIMI)

Description

The proportion of TIMI from grade 0 to 3 Pre -and post-PCI was evaluated.

Time Frame

day 0

Title

Corrected TIMI frame count（CTFC）

Description

The values of CTFC were evaluated and compared between groups.

Time Frame

day 0

Title

TIMI myocardial perfusion grade （TMBG）

Description

The proportion of TMPG from grade 0 to 3 Pre -and post-PCI was evaluated.

Time Frame

day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures; Patients with an allergic constitution; Patients who is participating in other clinical trials; Patients who do not give a signed informed consent forms; Patients who are not suitable to enroll in the trial according to the investigator's judgement.

Facility Information:

Facility Name

Peking University First hospiatl

City

Beijing

ZIP/Postal Code

100000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34478577

Citation

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.

Results Reference

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Anfibatide Phase Ib-IIa Clinical Trial

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