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Coronary Heart DiseasePhase 4NCT04826497

Effect of Nicorandil on Cardiac Sympathetic Nerve for the Patients of Acute ST Segment Elevation Myocardial Infarction

A Phase 4 study testing nicorandil in people with Coronary Heart Disease, run by Xuzhou Central Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators evaluate the effects of intracoronary and intravenous administration of nicorandil on cardiac sympathetic nerve activity and distribution in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Coronary Heart Disease
What is being tested?
nicorandil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
No sites listed yet
Study dates
Apr 2021to Feb 2022
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
  • Age20-80,All genders
  • anterior myocardial infarction
  • The first myocardial infarction
  • The infarct-related artery(IRA) is totally occlusive
  • Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
  • The time from myocardial infarction onset to reach the hospital is less than 12 hs

Who cannot join

  • kidney dysfunction (creatinine >2 mg/dl),
  • History of previous liver disease,
  • Cardiogenic shock,
  • History of myocardial infarction (MI)
  • History of coronary artery bypass grafting
  • History of allergic response to drugs
  • Severe hypovolemia

Trial locations and contacts

No sites are listed yet.

chunguang Feng, PhD contact

+8618936376559

fcg999@163.com

About this study

Official title: Effects of Nicorandil on Cardiac Sympathetic Nerve Activity and Distribution in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

The investigators evaluate the effects of intracoronary and intravenous administration of nicorandil on cardiac sympathetic nerve activity and distribution in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

Read the detailed description

Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and injury of cardiac sympathetic nerve, etc.

Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.

The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury especially injury of cardiac sympathetic nerve in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation,moreover,it could reduces the release of norepinephrine from sympathetic endings of the heart directly.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and injury of cardiac sympathetic nerve.

Being tested
nicorandil, Placebo（normal saline）
Keywords
nicorandil, primary percutaneous coronary intervention, acute ST segment elevation myocardial infarction, cardiac sympathetic nerve
Medical subject headings
Coronary Disease, ST Elevation Myocardial Infarction

What participants receive

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

  • nicorandilDrug

    Also called Experiment Group

    All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg nicorandil was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention

  • Placebo（normal saline）Drug

    Also called Control Group

    All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg placebo was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of placebo to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention

Study groups in NCT04826497
Study groupRoleWhat they receive
NicorandilExperimentalPatients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
Receives: Drug: nicorandil
Placebo （normal saline）Placebo comparatorPatients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention
Receives: Drug: Placebo（normal saline）

What is being measured

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

  1. Comparison of the delayed heart/mediastinum count (H/M) ratio

    The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images

    Measured: 10 days after primary PCI

Secondary outcomes (6)

  1. The total defect score (TDS)

    The total defect score was determined from 123I-meta-iodobenzylguanidine (MIBG) images

    Measured: 10 days after primary PCI

  2. Rate of slow re-flow/no-reflow phenomenon

    TIMI myocardial perfusion grade (TMPG) of the final coronary flow in the culprit artery

    Measured: 5 minutes after primary PCI

  3. Rate fo complete ST-segment resolution

    ST-segment resolution >50 percent in ECG

    Measured: 2 hours after primary PCI

  4. Rate of unplanned hospitalization for heart failure

    Rate of unplanned hospitalization for heart failure

    Measured: 6 months after primary PCI

  5. The washout rate (WR)

    The washout rate (WR) were determined from 123I-meta-iodobenzylguanidine (MIBG) images

    Measured: 10 days after primary PCI

  6. The total defect score (TDS)

    The total defect score was determined from 99mTc-pyrophosphate scintigraphy

    Measured: 7 days after primary PCI

Timeline

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

  1. First posted1 Apr 2021
  2. Study startApr 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionFeb 2022 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04826497
Sponsor's protocol ID
2021KC20122
Status last verified
Mar 2021
First submitted
23 Mar 2021
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

    PubMed 28886621

  • Piper HM, Meuter K, Schafer C. Cellular mechanisms of ischemia-reperfusion injury. Ann Thorac Surg. 2003 Feb;75(2):S644-8. doi: 10.1016/s0003-4975(02)04686-6.

    PubMed 12607706

  • Ji Z, Zhang R, Lu W, Ma G, Qu Y. The effect of nicorandil in patients with acute myocardial infarction undergoing percutaneous coronary intervention: a systematic review and meta-analysis. Ir J Med Sci. 2020 Feb;189(1):119-131. doi: 10.1007/s11845-019-02034-3. Epub 2019 May 30.

    PubMed 31147987

  • Xu L, Wang L, Li K, Zhang Z, Sun H, Yang X. Nicorandil prior to primary percutaneous coronary intervention improves clinical outcomes in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2019 Apr 29;13:1389-1400. doi: 10.2147/DDDT.S195918. eCollection 2019.

    PubMed 31118574

  • Fukui Y, Nozawa T, Ihori H, Sobajima M, Nakadate T, Matsuki A, Nonomura M, Fujii N, Inoue H, Kinugawa K. Nicorandil Attenuates Ischemia-Reperfusion Injury Via Inhibition of Norepinephrine Release From Cardiac Sympathetic Nerve Terminals. Int Heart J. 2017 Oct 21;58(5):787-793. doi: 10.1536/ihj.16-391. Epub 2017 Sep 30.

    PubMed 28966311

  • Kasama S, Toyama T, Kumakura H, Takayama Y, Ichikawa S, Suzuki T, Kurabayashi M. Effects of nicorandil on cardiac sympathetic nerve activity after reperfusion therapy in patients with first anterior acute myocardial infarction. Eur J Nucl Med Mol Imaging. 2005 Mar;32(3):322-8. doi: 10.1007/s00259-004-1672-0. Epub 2004 Oct 2.

    PubMed 15791442

  • Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048.

    PubMed 29495982

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nicorandil in people with Coronary Heart Disease, run by Xuzhou Central Hospital.

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 7 inclusion and 7 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 1 Apr 2021. 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 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?

Results are not available in the source record.

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

Contact chunguang Feng, PhD (+8618936376559, fcg999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the delayed heart/mediastinum count (H/M) ratio (time frame: 10 days after primary 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 NCT04826497, which also lists 7 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 1 Apr 2021.

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