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

NCT04632121 | Unknown DMC FDA Drug

• 1 other identifier: Nicorandil in STEMI Patients
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nicorandil

Outcome Measures

Primary Outcomes (2)

• Angiographic evidence of epicardial successful reperfusion

  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

  Angiographic evidence of tissue-level successful reperfusion (Myocardial blush grade).

  1 day around PCI

Secondary Outcomes (3)

• Electrocardiographic measures of repolarization dispersion

  after 90 minutes of PPCI

• Echocardiographic measures of LV recovery

  before discharge and at 3 months after index event.

• Speckle tracking for global longitudinal strain of left ventricle

  before discharge and at 3 months after index event

Study Arms (2)

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

Group B

will be given standard treatment, without nicorandil loading or maintainance.

Interventions

Nicorandil 20 MG DRUG

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

Also known as: PCI

Group A

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All STEMI patients undergoing primary PCI in Assiut university hospital

You may qualify if:

• Patients with STEMI eligible for PPCI.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed Abdel Nasser Abdel Rady: lead

Related Publications (8)

• 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.

  PMID: 31019762 BACKGROUND

• Feng 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.

  PMID: 29743901 BACKGROUND

• 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.

  PMID: 31118574 RESULT

• Wu 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.

  PMID: 24167609 RESULT

• Hausenloy 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.

  PMID: 23281415 RESULT

• Allen 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.

  PMID: 10972541 RESULT

• IONA 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.

  PMID: 11965271 RESULT

• P. Channel, A. Triphosphate, M. Infarction, A. T. Sensitive, and P. Channel, "Nicorandil Nicorandil," 2018.

  RESULT

MeSH Terms

Interventions

Nicorandil

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ahmed Abdel Naser

CONTACT

01011835549; ahmedabdelnaserabdelrady@gmail.com

Tarek Abdel Hammeed

CONTACT

01099975128; tarkaf76@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 17, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 29, 2023
• Last Updated: January 5, 2021

Record last verified: 2021-01