Oral Nicorandil in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

January 2, 2021 updated by: Ahmed Abdel Nasser Abdel Rady

Early Administration of Oral Nicorandil in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Randomized Controlled Trial

  • To study the effects of early oral administration of nicorandil in the setting of PPCI among STEMI patients on early angiographic, electrocardiographic, echocardiographic and hard clinical outcomes.
  • To assess the possible benefits of nicorandil on myocardial reperfusion through LGE- CMR substudy after 3 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Nicorandil is a nicotinamide ester that dilates peripheral and coronary resistance vessels via action on ATP-sensitive potassium channels and possesses a nitrate moiety that promotes systemic venous and coronary vasodilation. As a result of these dual actions, nicorandil reduces preload and afterload and results in an increase in coronary blood flow. In addition to these effects, nicorandil may have cardioprotective actions mediated through the activation of potassium channel .

Previous study on the effect of nicorandil on patients with stable angina has shown significant improvement in outcome due to a reduction in major coronary events.

Acute occlusion of the coronary artery in the STEMI patient subjects the myocardium supplied by that vessel to acute myocardial ischemia, thereby demarcating the area at risk (AAR) of potential MI, should the acute coronary occlusion be sustained or permanent. If the period of acute myocardial ischemia is prolonged (more than 20 minutes) a "wave front" of cardiomyocyte death begins in the subendocardium and extends transmurally over time toward the epicardium.

The deprivation of oxygen and nutrient supply results in a series of abrupt biochemical and metabolic changes within the myocardium. The absence of oxygen halts oxidative phosphorylation, leading to mitochondrial membrane depolarization, ATP depletion, and inhibition of myocardial contractile function.

Ischemia-Reperfusion injury (IRI) is defined as the paradoxical exacerbation of cellular dysfunction and death, following restoration of blood flow to previously ischemic tissues. Reestablishment of blood flow is essential to salvage ischemic tissues. However reperfusion itself paradoxically causes further damage, threatening function and viability of the organ.

Early intra-coronary administration of nicorandil has been shown to reduce the damage in the myocardial microcirculation caused by PPCI and the myocardial infarct size in patients with AMI .

Nicorandil prior to reperfusion was suggested to improve coronary flow. Furthermore, suppression of ventricular arrhythmia, and improvement of left ventricular function were demonstrated in patients who suffered from AMI and underwent primary PCI. But the definite clinical benefits of nicorandil were not found, which may be due to the small sample size of the selected studies .

Compared with intracoronary use alone, the intracoronary and peripheral intravenous use of nicorandil can better improve myocardial microcirculation and short-term prognosis .

Nicorandil use prior and post PCI could decrease the occurrence rate of ventricular arrhythmia in STEMI patients undergoing emergent PCI, and this effect might be related with reduced QTd and QTcd post medication .

Whether oral nicorandil, which is more widely available and more affordable, would have clinical benefits in terms of measures of reperfusion, and LV recovery post-STEMI, when administered in the early phase of STEMI is still questionable, and warrants further research.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All STEMI patients undergoing primary PCI in Assiut university hospital

Description

Inclusion Criteria:

  • Patients with STEMI eligible for PPCI.

Exclusion Criteria:

  • Patients undergoing other reperfusion strategies, including fibrinolysis, rescue PCI or pharmacoinvasive PCI.
  • Patients presenting with Cardiogenic shock or symptomatic hypotension (BP< 90/60 mmHg)
  • Patients who have contraindications for nicorandil e.g. advanced hepatic disease.
  • Patients not consenting to the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
will receive standard treatment + 20 mg nicorandil prior to PPCI, and then maintained on 20 mg b.i.d for 3 months .
Drug: Nicorandil 20 MG
Nicorandil is a nicotinamide ester that dilates peripheral and coronary resistance vessels via action on ATP-sensitive potassium channels and possesses a nitrate moiety that promotes systemic venous and coronary vasodilation. As a result of these dual actions, nicorandil reduces preload and afterload and results in an increase in coronary blood flow. In addition to these effects, nicorandil may have cardioprotective actions mediated through the activation of potassium channel
Other Names:
  • PCI
Group B
will be given standard treatment, without nicorandil loading or maintainance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic evidence of epicardial successful reperfusion
Time Frame: 1 day around PCI
Angiographic evidence of epicardil successful reperfusion including; TIMI flow grade, and TIMI frame count.
1 day around PCI
Angiographic evidence of tissue-level successful reperfusion
Time Frame: 1 day around PCI
Angiographic evidence of tissue-level successful reperfusion (Myocardial blush grade).
1 day around PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiographic measures of repolarization dispersion
Time Frame: after 90 minutes of PPCI
Electrocardiographic measures of repolarization dispersion including; QTc, QTD, T-peak to T-end interval (Tp-Te), and its dispersion, and Tp-Te/QT ratio, as well as ST segment resolution at 90 minutes from reperfusion.
after 90 minutes of PPCI
Echocardiographic measures of LV recovery
Time Frame: before discharge and at 3 months after index event.
Echocardiographic measures of LV recovery including; 2-D left ventricular ejection fraction, left ventricle volumes, Mitral regurge severity, and wall motion score index.
before discharge and at 3 months after index event.
Speckle tracking for global longitudinal strain of left ventricle
Time Frame: before discharge and at 3 months after index event
2D- Left ventricle Global longitudinal strain by speckle tracking echocardiography (only 50 patients in each group)
before discharge and at 3 months after index event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Abdel Nasser Abdel Rady

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 29, 2023

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (ACTUAL)

November 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 2, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nicorandil in STEMI Patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nicorandil

  • Chinese PLA General Hospital
    The Second Hospital of Hebei Medical University; Beijing Chao Yang Hospital; Guizhou... and other collaborators
    Completed
    China-Administration of Nicorandil Group（CHANGE）
    Myocardial Infarction | Percutaneous Coronary Intervention | Nicorandil
    China

Clinical Trials on Nicorandil 20 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe