Acute Anterior ST Segment Elevation Myocardial InfarctionPhase 1/2NCT05887830
Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
A Phase 1/2 study testing Nivolumab in people with Acute Anterior ST Segment Elevation Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Myocardial infarction (MI) is a major contributor to morbidity and mortality in China. The goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of Nivolumab to the patients presenting with an acute anterior ST-segmental elevated… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Anterior ST Segment Elevation Myocardial Infarction
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years;
- Signed informed consent and expected compliance with protocol;
- Acute anterior ST segment elevation myocardial infarction;
- Emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset;
- Left ventricular ejection fraction is less than 45% (LVEF≤45%) as revealed by Echo within 72 hours after revascularization.
Who cannot join
- Cardiogenic shock;
- Cardiac arrest/ventricular fibrillation;
- History of severe renal failure, glomerular filtration rate (eGFR) < 30ml/min;
- History of severe infection, hepatobiliary obstruction or malignant tumor;
- Receiving immunosuppressive therapy;
- Women who are pregnant or may become pregnant;
- There are contraindications to study drugs or magnetic resonance examination;
- No written informed consent was obtained.
Trial locations and contacts
No sites are listed yet.
About this study
Myocardial infarction (MI) is a major contributor to morbidity and mortality in China. The goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of Nivolumab to the patients presenting with an acute anterior ST-segmental elevated myocardial infarction. Researchers will investigate if Nivolumab treatment can effectively and safely reduce infarct size as well as improve cardiac function of the patients with acute myocardial infarction.
Read the detailed description
The efficacy and safety of nivolumab as compared with placebo in the treatment of acute anterior ST segment elevation myocardial infarction are not known. In this phase 1/2, randomized, placebo-controlled, open-label trial, we randomly assigned adults with acute anterior ST segment elevation myocardial infarction to receive either nivolumab (5mg/kg for single administration) or placebo. The primary end points were difference in infarct size/LV mass% from baseline to 3 months after Nivolumab administration and the incidence of adverse events during 3 months after Nivolumab administration. Secondary end points included difference in LVEF%, LVESV/Body surface area, LVEDV/Body surface area, Trponin T and proBNP from baseline to 3 months after Nivolumab administration.
- Being tested
- Nivolumab, Placebo
- Keywords
- Nivolumab, acute anterior ST segment elevation myocardial infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Single administration of Nivolumab on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. The active drug Nivolumab will be administered at a standard dose (5mg/kg) dissolved in 100ml 0.9%NaCl solution. Nivolumab was given at a rate of 15-25 drops per minute, and the intravenous infusion time exceeded 1 hour.
PlaceboOther
Single administration of Placebo on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. Patients assigned to the placebo treatment group will receive an intravenous infusion of 100 ml 0.9% NaCl solution at a rate of 15-25 drops/min for an IV infusion duration of more than 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Interventional drug treatment group | Experimental | The participants receive Nivolumab treatment. The active drug Nivolumab will be administered at a standard dose (5mg/kg) dissolved in 100ml 0.9%NaCl solution. Nivolumab was given at a rate of 15-25 drops per minute, and the intravenous infusion time exceeded 1 hour. Receives: Drug: Nivolumab |
| Placebo treatment group | Placebo comparator | The participants receive placebo treatment. Patients assigned to the placebo treatment group will receive an intravenous infusion of 100 ml 0.9% NaCl solution at a rate of 15-25 drops/min for an IV infusion duration of more than 1 hour. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
∆Infarct size/Left Ventricular mass%
Difference in Infarct size/Left ventricular mass% from baseline to 3 months after Nivolumab administration.
Measured: 3 months
The incidence of adverse events
The incidence of adverse events during 3 months after Nivolumab treatment.
Measured: up to 3 months
Secondary outcomes (5)
∆Left ventricle ejection fraction%
Difference in Left ventricle ejection fraction% from baseline to 3 months after Nivolumab administration.
Measured: 3 months
∆Left ventricle end systolic volume/Body surface area
Difference in Left ventricle end systolic volume/Body surface area from baseline to 3 months after Nivolumab administration.
Measured: 3 months
∆Left ventricle end diastolic volume/Body surface area
Difference in Left ventricle end diastolic volume/Body surface area from baseline to 3 months after Nivolumab administration.
Measured: 3 months
∆Troponin T
Difference in concentration of Troponin T from baseline to 3 months after Nivolumab administration.
Measured: 3 months
∆proBNP
Difference in concentration of proBNP from baseline to 3 months after Nivolumab administration.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Anterior ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyang Hu, PhD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887830
- Sponsor's protocol ID
- YAN2023-0193
- Status last verified
- May 2023
- First submitted
- 24 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05887830
- Acronym / sponsor ID
- YAN2023-0193
- Keywords
- Nivolumab, acute anterior ST segment elevation myocardial infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jun 2023 (actual)
- 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.
Myocardial infarction (MI) is a major contributor to morbidity and mortality in China. The goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of Nivolumab to the patients presenting with an acute anterior ST-segmental elevated myocardial infarction. Researchers will investigate if Nivolumab treatment can effectively and safely reduce infarct size as well as improve cardiac function of the patients with acute myocardial infarction.
Detailed description
The efficacy and safety of nivolumab as compared with placebo in the treatment of acute anterior ST segment elevation myocardial infarction are not known. In this phase 1/2, randomized, placebo-controlled, open-label trial, we randomly assigned adults with acute anterior ST segment elevation myocardial infarction to receive either nivolumab (5mg/kg for single administration) or placebo. The primary end points were difference in infarct size/LV mass% from baseline to 3 months after Nivolumab administration and the incidence of adverse events during 3 months after Nivolumab administration. Secondary end points included difference in LVEF%, LVESV/Body surface area, LVEDV/Body surface area, Trponin T and proBNP from baseline to 3 months after Nivolumab administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional drug treatment group | Experimental | Drug: NivolumabThe participants receive Nivolumab treatment. The active drug Nivolumab will be administered at a standard dose (5mg/kg) dissolved in 100ml 0.9%NaCl solution. Nivolumab was given at a rate of 15-25 drops per minute, and the intravenous infusion time exceeded 1 hour. |
| Placebo treatment group | Placebo comparator | Other: PlaceboThe participants receive placebo treatment. Patients assigned to the placebo treatment group will receive an intravenous infusion of 100 ml 0.9% NaCl solution at a rate of 15-25 drops/min for an IV infusion duration of more than 1 hour. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years;
- Signed informed consent and expected compliance with protocol;
- Acute anterior ST segment elevation myocardial infarction;
- Emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset;
- Left ventricular ejection fraction is less than 45% (LVEF≤45%) as revealed by Echo within 72 hours after revascularization.
Key exclusion criteria (8 listed)
- Cardiogenic shock;
- Cardiac arrest/ventricular fibrillation;
- History of severe renal failure, glomerular filtration rate (eGFR) < 30ml/min;
- History of severe infection, hepatobiliary obstruction or malignant tumor;
- Receiving immunosuppressive therapy;
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 |
|---|---|---|
| NivolumabSingle administration of Nivolumab on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. The active drug Nivolumab will be administered at a standard dose (5mg/kg) dissolved in 100ml 0.9%NaCl solution. Nivolumab was given at a rate of 15-25 drops per minute, and the intravenous infusion time exceeded 1 hour. | Drug | Interventional drug treatment group |
| PlaceboSingle administration of Placebo on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. Patients assigned to the placebo treatment group will receive an intravenous infusion of 100 ml 0.9% NaCl solution at a rate of 15-25 drops/min for an IV infusion duration of more than 1 hour. | Other | Placebo treatment group |
Primary outcome
∆Infarct size/Left Ventricular mass%
Time frame: 3 months
Difference in Infarct size/Left ventricular mass% from baseline to 3 months after Nivolumab administration.
The incidence of adverse events
Time frame: up to 3 months
The incidence of adverse events during 3 months after Nivolumab treatment.
5 secondary outcomes
∆Left ventricle ejection fraction%
Time frame: 3 months
∆Left ventricle end systolic volume/Body surface area
Time frame: 3 months
∆Left ventricle end diastolic volume/Body surface area
Time frame: 3 months
∆Troponin T
Time frame: 3 months
∆proBNP
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Xinyang Hu, PhD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivolumab in people with Acute Anterior ST Segment Elevation Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 8 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 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinchuan Xu, PhD (86-13968126628, lsyrmxyc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
∆Infarct size/Left Ventricular mass% (time frame: 3 months). 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?
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 8 Jun 2023.