NicorandilNCT04632121
Oral Nicorandil in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention
An observational study of Nicorandil, run by Ahmed Abdel Nasser Abdel Rady.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Nicorandil
- What is being tested?
- Nicorandil 20 MG
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 29 Dec 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All STEMI patients undergoing primary PCI in Assiut university hospital
Who may be able to join
- Patients with STEMI eligible for PPCI.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nicorandil
- Being tested
- Nicorandil 20 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil 20 MGDrug
Also called PCI
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | will receive standard treatment + 20 mg nicorandil prior to PPCI, and then maintained on 20 mg b.i.d for 3 months . Receives: Drug: Nicorandil 20 MG | |
| Group B | will be given standard treatment, without nicorandil loading or maintainance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic evidence of epicardial successful reperfusion
Angiographic evidence of epicardil successful reperfusion including; TIMI flow grade, and TIMI frame count.
Measured: 1 day around PCI
Angiographic evidence of tissue-level successful reperfusion
Angiographic evidence of tissue-level successful reperfusion (Myocardial blush grade).
Measured: 1 day around PCI
Secondary outcomes (3)
Electrocardiographic measures of repolarization dispersion
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.
Measured: after 90 minutes of PPCI
Echocardiographic measures of LV recovery
Echocardiographic measures of LV recovery including; 2-D left ventricular ejection fraction, left ventricle volumes, Mitral regurge severity, and wall motion score index.
Measured: before discharge and at 3 months after index event.
Speckle tracking for global longitudinal strain of left ventricle
2D- Left ventricle Global longitudinal strain by speckle tracking echocardiography (only 50 patients in each group)
Measured: before discharge and at 3 months after index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Apr 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NicorandilStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ahmed Abdel Nasser Abdel Rady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Abdel Nasser Abdel Rady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632121
- Sponsor's protocol ID
- Nicorandil in STEMI Patients
- Status last verified
- Jan 2021
- First submitted
- 31 Oct 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pi SF, Liu YW, Li T, Wang Y, Zhou Q, Liu BJ, Peng WJ, Li X, Wang YY, Huang L. Effect of sequential nicorandil on myocardial microcirculation and short-term prognosis in acute myocardial infarction patients undergoing coronary intervention. J Thorac Dis. 2019 Mar;11(3):744-752. doi: 10.21037/jtd.2019.02.23.
PubMed 31019762Feng C, Han B, Liu Y, Wang L, Niu D, Lou M, Lu C. Effect of nicorandil administration on myocardial microcirculation during primary percutaneous coronary intervention in patients with acute myocardial infarction. Postepy Kardiol Interwencyjnej. 2018;14(1):26-31. doi: 10.5114/aic.2018.74352. Epub 2018 Mar 22.
PubMed 29743901Xu 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 31118574Wu M, Huang Z, Xie H, Zhou Z. Nicorandil in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention: a systematic review and meta-analysis. PLoS One. 2013 Oct 22;8(10):e78231. doi: 10.1371/journal.pone.0078231. eCollection 2013.
PubMed 24167609Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
PubMed 23281415Allen DG, Xiao XH. Activity of the Na+/H+ exchanger contributes to cardiac damage following ischaemia and reperfusion. Clin Exp Pharmacol Physiol. 2000 Sep;27(9):727-33. doi: 10.1046/j.1440-1681.2000.03329.x.
PubMed 10972541IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. Lancet. 2002 Apr 13;359(9314):1269-75. doi: 10.1016/S0140-6736(02)08265-X.
PubMed 11965271P. Channel, A. Triphosphate, M. Infarction, A. T. Sensitive, and P. Channel, "Nicorandil Nicorandil," 2018.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of Oral Nicorandil in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04632121
- Acronym / sponsor ID
- Nicorandil in STEMI Patients
- Conditions
- Nicorandil
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ahmed Abdel Nasser Abdel RadyUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 17 Nov 2020 (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.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Nicorandil 20 MGwill receive standard treatment + 20 mg nicorandil prior to PPCI, and then maintained on 20 mg b.i.d for 3 months . |
| Group B | – | –will be given standard treatment, without nicorandil loading or maintainance. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All STEMI patients undergoing primary PCI in Assiut university hospital
Key inclusion criteria (1 listed)
- Patients with STEMI eligible for PPCI.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Nicorandil 20 MGAlso: PCINicorandil 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 | Drug | Group A |
Primary outcome
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.
Angiographic evidence of tissue-level successful reperfusion
Time frame: 1 day around PCI
Angiographic evidence of tissue-level successful reperfusion (Myocardial blush grade).
3 secondary outcomes
Electrocardiographic measures of repolarization dispersion
Time frame: after 90 minutes of PPCI
Echocardiographic measures of LV recovery
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 31019762Pi SF, Liu YW, Li T, Wang Y, Zhou Q, Liu BJ, Peng WJ, Li X, Wang YY, Huang L. Effect of sequential nicorandil on myocardial microcirculation and short-term prognosis in acute myocardial infarction patients undergoing coronary intervention. J Thorac Dis. 2019 Mar;11(3):744-752. doi: 10.21037/jtd.2019.02.23.
- Background: PubMed 29743901Feng C, Han B, Liu Y, Wang L, Niu D, Lou M, Lu C. Effect of nicorandil administration on myocardial microcirculation during primary percutaneous coronary intervention in patients with acute myocardial infarction. Postepy Kardiol Interwencyjnej. 2018;14(1):26-31. doi: 10.5114/aic.2018.74352. Epub 2018 Mar 22.
- Results publication: PubMed 31118574Xu 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.
- Results publication: PubMed 24167609Wu M, Huang Z, Xie H, Zhou Z. Nicorandil in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention: a systematic review and meta-analysis. PLoS One. 2013 Oct 22;8(10):e78231. doi: 10.1371/journal.pone.0078231. eCollection 2013.
- Results publication: PubMed 23281415Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
- Results publication: PubMed 10972541Allen DG, Xiao XH. Activity of the Na+/H+ exchanger contributes to cardiac damage following ischaemia and reperfusion. Clin Exp Pharmacol Physiol. 2000 Sep;27(9):727-33. doi: 10.1046/j.1440-1681.2000.03329.x.
- Results publication: PubMed 11965271IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. Lancet. 2002 Apr 13;359(9314):1269-75. doi: 10.1016/S0140-6736(02)08265-X.
- Results publicationP. Channel, A. Triphosphate, M. Infarction, A. T. Sensitive, and P. Channel, "Nicorandil Nicorandil," 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicorandil, run by Ahmed Abdel Nasser Abdel Rady.
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 1 inclusion and 4 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 5 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ahmed Abdel Naser (01011835549, ahmedabdelnaserabdelrady@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic evidence of epicardial successful reperfusion (time frame: 1 day around PCI). 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?
On the ClinicalTrials.gov record for NCT04632121, which also lists 8 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 5 Jan 2021.