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Cardiovascular DiseasesPhase 4NCT06155110

A Randomized, Single-blind, Controlled Clinical Study of Cardiomyopeptidin on Improving Ischemia-reperfusion Injury in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI

A Phase 4 study testing cardiomyopeptidin in people with Cardiovascular Diseases, run by Chinese PLA General Hospital 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

This study aim to investigate the myocardium protection effect of cardiomyopeptidin in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
cardiomyopeptidin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
1 Nov 2019to 1 May 2025
Phase
Phase 4
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

  • STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
  • patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

Who cannot join

  • had once treated by ivabradine
  • history of myocardial infarction
  • mechanical complications
  • Unable to perform myocardial MRI
  • liver and kidney failure
  • malignant tumor
  • unconscious
  • Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: Chinese People's Liberation Army General Hospital

This study aim to investigate the myocardium protection effect of cardiomyopeptidin in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.

Read the detailed description

Investigators will enroll 160 patients with STEMI who were admitted to the Chinese PLA General Hospital between March 2022 and Marchr 2024，the investigators randomly assign eligible patients in a 1:1 ratio to either cardiomyopeptidin intervention group or control group befor primary PCI. The cardiomyopeptidin intervention group patients received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). and secondary endpoints include slow flow/no-reflow incidence, corrected TIMI frame count (cTFC), ST-segment fall rate of ECG, cardiac enzymes and troponin, area of myocardial edema, microvascular obstruction, left ventricular ejection fraction, and composite cardiovascular events during the study period: all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Being tested
cardiomyopeptidin
Medical subject headings
Cardiovascular Diseases

What participants receive

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

  • cardiomyopeptidinDrug

    cardiomyopeptidin intervention group will accept cardiomyopeptidin (Dalian Zhenao Pharmaceutical Co., Ltd., approval number: National Drug Approval No. H20052173, specification: 20 mg/tube) 3 mg/(kg·d)；

Study groups in NCT06155110
Study groupRoleWhat they receive
Cardiomyopeptidin groupExperimentalThe Cardiomyopeptidin group received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation
Receives: Drug: cardiomyopeptidin
The control groupNo interventionNot described

What is being measured

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

  1. Myocardial infarct size according to MR delayed enhancement scan

    Two experienced MRI cardiologists analyzed the delayed enhancement image

    Measured: 7 days after PCI

Secondary outcomes (6)

  1. MACEs

    MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization

    Measured: follow up in six months

  2. myocardial edema area

    Two experienced MRI cardiologists analyzed the delayed enhancement image

    Measured: 7 days after PCI

  3. microvascular obstruction and left ventricular ejection fraction

    Two experienced MRI cardiologists analyzed the delayed enhancement image

    Measured: 7 days after PCI

  4. incidence of slow flow/no-reflow

    Angiographic slow/no-reflow during PCI was defined as thrombolysis in myocardial infarction (TIMI) flow grade ≤ 2 during the procedure without evidence of dissection

    Measured: Immediately after PCI

  5. corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC);

    The cTFC was measured by two cardiologists, and the average value was taken. When scanning at a rate of 15 frames per second, cTFC > 20 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI.

    Measured: Immediately after PCI

  6. ST-segment fall rate of electrocardiogram (ECG)

    Measured: 6 hours, 12 hours, 24 hours after myocardial infarction

Timeline

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

  1. First posted4 Dec 2023
  2. Study start1 Nov 2019
  3. Primary completion1 Mar 2025
  4. Study completion1 May 2025

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06155110
Sponsor's protocol ID
2023QG-1124
Status last verified
Nov 2023
First submitted
25 Nov 2023
Last updated
22 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Der P, Cui J, Das DK. Role of lipid rafts in ceramide and nitric oxide signaling in the ischemic and preconditioned hearts. J Mol Cell Cardiol. 2006 Feb;40(2):313-20. doi: 10.1016/j.yjmcc.2005.10.005. Epub 2005 Dec 9.

    PubMed 16337960

  • Salloum FN, Ockaili RA, Wittkamp M, Marwaha VR, Kukreja RC. Vardenafil: a novel type 5 phosphodiesterase inhibitor reduces myocardial infarct size following ischemia/reperfusion injury via opening of mitochondrial K(ATP) channels in rabbits. J Mol Cell Cardiol. 2006 Mar;40(3):405-11. doi: 10.1016/j.yjmcc.2005.10.002. Epub 2006 Feb 9.

    PubMed 16480739

  • Yang LP, Kong XP, Li RB, Zeng PL. [Recovery effect of cardiomyopeptidin fractions and fraction addition on cardiac muscle cells in rats damaged by adriamycin]. Zhongguo Zhong Yao Za Zhi. 2000 Jun;25(6):362-3. Chinese.

    PubMed 12512426

  • Yang LP, Wan HY, Kong XP, Wu Y, Teng J, Fan LL. [Preventive effect of cardiomyopeptidin on rat heart injured by ischemia-reperfusion]. Zhongguo Zhong Yao Za Zhi. 2000 Feb;25(2):105-7. Chinese.

    PubMed 12212070

  • Yang L, Chen L, Zhang G, Liu X, Chen D, Dong Y. [Effect of cardiomyopeptidin for injection on energy metabolism in isolated hearts of young rats after ischemia-reperfusion injury]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2010 Jun;35(6):598-606. doi: 10.3969/j.issn.1672-7347.2010.06.010. Chinese.

    PubMed 20622333

  • Korosoglou G, Giusca S, Montenbruck M, Patel AR, Lapinskas T, Gotze C, Zieschang V, Al-Tabatabaee S, Pieske B, Florian A, Erley J, Katus HA, Kelle S, Steen H. Fast Strain-Encoded Cardiac Magnetic Resonance for Diagnostic Classification and Risk Stratification of Heart Failure Patients. JACC Cardiovasc Imaging. 2021 Jun;14(6):1177-1188. doi: 10.1016/j.jcmg.2020.10.024. Epub 2021 Jan 13.

    PubMed 33454266

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing cardiomyopeptidin in people with Cardiovascular Diseases, run by Chinese PLA General Hospital 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 2 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: finished, as of the sponsor's last update on 22 May 2025. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Myocardial infarct size according to MR delayed enhancement scan (time frame: 7 days after PCI). 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 NCT06155110, which also lists 6 linked publications.

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 22 May 2025.

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