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Non-ST Segment Elevation Myocardial InfarctionPhase 1/2NCT01585259

Anfibatide Phase Ib-IIa Clinical Trial

A Phase 1/2 study testing Anfibatide in people with Non-ST Segment Elevation Myocardial Infarction, run by Lee's Pharmaceutical Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction patients Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Anfibatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
Jul 2012to Jul 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First hospiatl

    Beijing, 100000

Other trials in China

About this study

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).

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

Read the 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.
Being tested
Anfibatide, Placebo
Keywords
anti-platelet;, safety;, efficacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnfibatideDrug

    Snake venom

  • PlaceboDrug

    Saline

Study groups in NCT01585259
Study groupRoleWhat they receive
AnfibatideActive comparatorBolus 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
Receives: Drug: Anfibatide
PlaceboPlacebo comparatorBolus 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Platelet aggregation

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

    Measured: up to 48 hours

  2. Bleeding events

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

    Measured: Day 0 to day 30

Secondary outcomes (6)

  1. Mortality

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

    Measured: 30 days after treatment

  2. Safety Endpoints

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

    Measured: Day 0 to day 30

  3. Thrombosis formation

    Thrombosis formation after stent implantation:

    Measured: 48 hours after infusion during operation

  4. Thrombolysis in myocardial infraction (TIMI)

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

    Measured: day 0

  5. Corrected TIMI frame count（CTFC）

    The values of CTFC were evaluated and compared between groups.

    Measured: day 0

  6. TIMI myocardial perfusion grade （TMBG）

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

    Measured: day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585259
Sponsor's protocol ID
Lees_Anfibatide_Phase2
Status last verified
Jul 2015
First submitted
24 Apr 2012
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34478577

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anfibatide in people with Non-ST Segment Elevation Myocardial Infarction, run by Lee's Pharmaceutical Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Platelet aggregation (time frame: up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01585259, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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