ST Segment Elevation Myocardial InfarctionPhase 2NCT02495012
Anfibatide Treatment in STEMI Patients
A Phase 2 study testing Anfibatide in people with ST Segment Elevation Myocardial Infarction, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction
- 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
- 240 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to May 2016
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years;
- Fulfill the standard of direct PCI: ST Segment Elevation Myocardial Infarction occurred < 12 hours (ST Segment Elevation or New Left Bundle Branch Block (LBBB), combined myocardial ischemia chest pain medical history or the dynamic change of cardiac marker (troponin and/or CK-MB);
- Patients who will receive PCI and suitable for angioplasty and stent placement;
- Patients, or their family or guardian give signed informed consent forms.
Who cannot join
- Patients with weight < 50kg;
- Patients with severe hepatic or renal dysfunction, alanine aminotransferase (ALT) exceeds 3 times the normal maximum reference level, creatinine clearance level < 30ml/min or serum creatinine ≥ 200μmol/L or ≥2.5mg/dl;
- Patients with severe hemodynamic instability;
- Patients who will receive 2 times or more PCI treatment;
- Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
- Patients with untreated hypertension (SBP > 180mmHg or DBP > 110mmHg) or hypotension shock (SBP < 90mmHg);
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- Patients received GPIIb/IIIa receptor antagonists and/or thrombolytic therapy before randomization;
- Used eptifibatide and tirofiban in the past 12 hours before the randomization;
- Used abxicimab in the past 7 days before the randomization;
- Have received thrombolytic therapy before the randomization;
- Patients who need a long-term treatment of clopidogrel;
- Patients who have received enoxaparin sodium injection before the surgery;
- Patients who have hemorrhage risk:
- Suffered from ischemic stroke or transient ischemic attack (TIA) in the past 12 months;
- Suffered from hemorrhage stroke, or other life-long neuronal dysfunction;
- Suffered from tumor, arteriovenous malformation in brain and aneurysms;
- Suffered from traumatic brain injury in the past 3 months, or received major surgery;
- Received percutaneous coronary intervention (PCI) in the past 6 months;
- Have received coronary artery bypass graft therapy (CABG);
- Receiving long-term oral anticoagulants therapy;
- Suffered from active peptic ulcer, urinary and reproductive tract hemorrhage, or other active hemorrhage.
- Patients with coagulation disorder:
- Known as international normalized ratio > 2*;
- Patients with coagulation abnormalities or other hemorrhagic tendency (including inherited hemorrhagic diseases, e.g. Von Willebrand disease or hemophilia; acquired hemorrhagic diseases; and other clinically identified hemorrhagic diseases with unsolved rationale);
- Hematology test shows platelet count < 100x109mm3/L, or hemoglobin < 100g/L;
- Recorded clopidogrel-related thrombocytopenia or agranulocytosis;
- Life expectancy < 1 year;
- Patients who have implemented with pacemaker, and contraindicated to MRI examination;
- Patients who are allergic constitution or allergic to any component of aspirin, clopidogrel, creatinine, antiplatelet thrombolysin and investigational product;
- Women in pregnant or lactation period, or women of child-bearing age do not take efficient contraception measures;
- Patients who are participating or will be participating in other clinical trials;
- Patients who have participated in clinical trials of antiplatelet thrombolysin or other related trials;
- Patients who are not suitable for participating in this clinical trial according to the investigator's judgment, including who are unable or unwilling to follow the protocol;
- Patients who participated in other clinical trials in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centered, Randomized, Double-blinded, Placebo-Parallel Controlled Phase IIb Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin Injection for the Treatment of Patients With ST Segment Elevation Myocardial Infarction (STEMI) Before Receiving PCI Therapy.
A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Read the detailed description
Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1\&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
- Being tested
- placebo, Anfibatide
- Keywords
- efficacy, safety, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Freeze-dried powder without snake venom will be dissovled in saline
AnfibatideDrug
Freeze-dried powder with snake venom will be dissovled in saline
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours Receives: Drug: placebo |
| treatment | Active comparator | 5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours Receives: Drug: Anfibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of TMPG grade 2 and grade 3
After PCI, TMPG grade will be evaluated and
Measured: within 24 hours
Secondary outcomes (9)
inhibition rate of platelet aggregation and GP1b receptor combination rate
Baseline, 15-20 minutes after injection, 24-26 hours after injection, 48-50 hours after injection, 8-10 hours after the cease of medication, the comment and analysis of the inhibition rate of platelet aggregation and GP1b receptor combination rate
Measured: 48 hours
Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy
Measured: 24 hours
Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy
Measured: 24 hours
The depression level of ST segment from right after the PCI therapy to 2 hours later
- Complete: depression level ≥ 70% ii. Partially: 30% ≤ depression level < 70% iii. None: < 30%
Measured: within 24 hours
Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively
Measured: 72 hours
(6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)
Measured: 5 days
(7) While surgery and hospitalization, follow the ratio and dose as suggested by the surgeon in case of emergency use of GP IIb/IIIa receptor antagonist or other antiplatelet drug
Measured: 5 days
(8) Clinical endpoint 30 days after surgery (caused by death, non-fatal myocardial infarction reissue, blood clot formation after stent implantation, non-fatal stroke, target lesion revascularization reissue) and the analysis of the causes
Measured: 30days
Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495012
- Sponsor's protocol ID
- LeesPahrm_Anfibatide_Phase2b
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centered, Randomized, Double-blinded, Placebo-Parallel Controlled Phase IIb Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin Injection for the Treatment of Patients With ST Segment Elevation Myocardial Infarction (STEMI) Before Receiving PCI Therapy.
- ClinicalTrials.gov ID
- NCT02495012
- Acronym / sponsor ID
- LeesPahrm_Anfibatide_Phase2b
- Keywords
- efficacy, safety, STEMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Detailed description
Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1\&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: placebo5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours |
| treatment | Active comparator | Drug: Anfibatide5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-75 years;
- Fulfill the standard of direct PCI: ST Segment Elevation Myocardial Infarction occurred < 12 hours (ST Segment Elevation or New Left Bundle Branch Block (LBBB), combined myocardial ischemia chest pain medical history or the dynamic change of cardiac marker (troponin and/or CK-MB);
- Patients who will receive PCI and suitable for angioplasty and stent placement;
- Patients, or their family or guardian give signed informed consent forms.
Key exclusion criteria (34 listed)
- Patients with weight < 50kg;
- Patients with severe hepatic or renal dysfunction, alanine aminotransferase (ALT) exceeds 3 times the normal maximum reference level, creatinine clearance level < 30ml/min or serum creatinine ≥ 200μmol/L or ≥2.5mg/dl;
- Patients with severe hemodynamic instability;
- Patients who will receive 2 times or more PCI treatment;
- Patients with heart function in decompensatory phase (Killip grade 3-4) or cardiac shock;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboFreeze-dried powder without snake venom will be dissovled in saline | Drug | control |
| AnfibatideFreeze-dried powder with snake venom will be dissovled in saline | Drug | treatment |
Primary outcome
ratio of TMPG grade 2 and grade 3
Time frame: within 24 hours
After PCI, TMPG grade will be evaluated and
9 secondary outcomes
inhibition rate of platelet aggregation and GP1b receptor combination rate
Time frame: 48 hours
Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy
Time frame: 24 hours
Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy
Time frame: 24 hours
The depression level of ST segment from right after the PCI therapy to 2 hours later
Time frame: within 24 hours
Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively
Time frame: 72 hours
(6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)
Time frame: 5 days
(7) While surgery and hospitalization, follow the ratio and dose as suggested by the surgeon in case of emergency use of GP IIb/IIIa receptor antagonist or other antiplatelet drug
Time frame: 5 days
(8) Clinical endpoint 30 days after surgery (caused by death, non-fatal myocardial infarction reissue, blood clot formation after stent implantation, non-fatal stroke, target lesion revascularization reissue) and the analysis of the causes
Time frame: 30days
Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)
Time frame: 30days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anfibatide in people with 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 4 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 13 Jul 2015. 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 phase mean?
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?
Results are not available in the source record.
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?
ratio of TMPG grade 2 and grade 3 (time frame: within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2015.