Effect of Nicorandil for the Patients of Acute ST Segment Elevation Myocardial Infarction

NCT02435797 | Unknown Phase 4 DMC

• 1 other identifier: W201416
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI) reduces reperfusion injury.

Conditions

Coronary Heart Disease

Keywords

nicorandil; primary percutaneous coronary intervention; acute ST segment elevation myocardial infarction; thrombus aspiration

Outcome Measures

Primary Outcomes (1)

• Primary composite endpoint (whether premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether severity of chest pain is aggravated,and number of episodes chest pain)

  The primary composite endpoint consisted of reperfusion-induced arrhythmia, worsening of chest pain, and no-reflow/slow reflow. In perioperative period,we will observe whether the reperfusion-induced arrhythmia including atrial or ventricular premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether the severity of chest pain is aggravated,and the number of episodes of chest pain will be recorded for patients who complains of chest pain that lasted for at least 30 min within the 24 h following onset of MI;Whether the phenomenon of no-reflow/slow reflow appears.No-reflow and slow flow are diagnosed when the thrombolysis in myocardial infarction(TIMI) flow grade is 2 or lower,despite successful PCI such as balloon angioplasty or stent insertion.

  24hours

Secondary Outcomes (1)

• the combined outcome of TIMI frame count (cTFC) of CAG and ST resolution (STR) of ECG

  24hours

Study Arms (2)

Nicorandil

ACTIVE COMPARATOR

Nicorandil for injection

Drug: Nicorandil

normal saline

PLACEBO COMPARATOR

normal saline

Drug: normal saline

Interventions

Nicorandil DRUG

All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Subjects in the NicorandilGroup were then given 2 mg intracoronary nicorandil through the lesions via thrombus aspiration catheter, and an additional intracoronary dose of 2 mg nicorandil before stent implantation. A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects.

Nicorandil

normal saline DRUG

All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Normal saline in the Placebo Group were then given 2 ml through the lesions via thrombus aspiration catheter,and an additional intracoronary dose of 2 ml before stent implantation. A minimum 5-min interval occurred between the first and second injection.

normal saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ST Segment Elevation Myocardial Infarction (ASTEMI) defined as typical chest pain lasting \>30min within the previous 12 h, with a clear ST-segment elevation of \>0.1millivolt(mV) in ≥2 contiguous electrocardiographic leads, and the value of troponin I(TNI) above the maximum peak in the normal range.
• Age20-80,All genders
• The first myocardial infarction, and there is no history of PCI therapy and coronary artery bypass grafting
• 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
• Successful interventional treatment, the residual stenosis of IRA is less than 30% ,
• TIMI flow grade 3

You may not qualify if:

• 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
• Right ventricular infarction
• Severe hypovolemia

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (14)

• Moens AL, Claeys MJ, Timmermans JP, Vrints CJ. Myocardial ischemia/reperfusion-injury, a clinical view on a complex pathophysiological process. Int J Cardiol. 2005 Apr 20;100(2):179-90. doi: 10.1016/j.ijcard.2004.04.013.

  PMID: 15823623 BACKGROUND

• Reffelmann T, Kloner RA. The "no-reflow" phenomenon: basic science and clinical correlates. Heart. 2002 Feb;87(2):162-8. doi: 10.1136/heart.87.2.162. No abstract available.

  PMID: 11796561 BACKGROUND

• Costantini CO, Stone GW, Mehran R, Aymong E, Grines CL, Cox DA, Stuckey T, Turco M, Gersh BJ, Tcheng JE, Garcia E, Griffin JJ, Guagliumi G, Leon MB, Lansky AJ. Frequency, correlates, and clinical implications of myocardial perfusion after primary angioplasty and stenting, with and without glycoprotein IIb/IIIa inhibition, in acute myocardial infarction. J Am Coll Cardiol. 2004 Jul 21;44(2):305-12. doi: 10.1016/j.jacc.2004.03.058.

  PMID: 15261923 BACKGROUND

• Tanaka A, Kawarabayashi T, Nishibori Y, Sano T, Nishida Y, Fukuda D, Shimada K, Yoshikawa J. No-reflow phenomenon and lesion morphology in patients with acute myocardial infarction. Circulation. 2002 May 7;105(18):2148-52. doi: 10.1161/01.cir.0000015697.59592.07.

  PMID: 11994247 BACKGROUND

• Limbruno U, De Carlo M, Pistolesi S, Micheli A, Petronio AS, Camacci T, Fontanini G, Balbarini A, Mariani M, De Caterina R. Distal embolization during primary angioplasty: histopathologic features and predictability. Am Heart J. 2005 Jul;150(1):102-8. doi: 10.1016/j.ahj.2005.01.016.

  PMID: 16084155 BACKGROUND

• De Luca G, Navarese EP, Suryapranata H. A meta-analytic overview of thrombectomy during primary angioplasty. Int J Cardiol. 2013 Jul 1;166(3):606-12. doi: 10.1016/j.ijcard.2011.11.102. Epub 2012 Jan 28.

  PMID: 22284272 BACKGROUND

• Werner GS, Lang K, Kuehnert H, Figulla HR. Intracoronary verapamil for reversal of no-reflow during coronary angioplasty for acute myocardial infarction. Catheter Cardiovasc Interv. 2002 Dec;57(4):444-51. doi: 10.1002/ccd.10375.

  PMID: 12455077 BACKGROUND

• Marzilli M, Orsini E, Marraccini P, Testa R. Beneficial effects of intracoronary adenosine as an adjunct to primary angioplasty in acute myocardial infarction. Circulation. 2000 May 9;101(18):2154-9. doi: 10.1161/01.cir.101.18.2154.

  PMID: 10801755 BACKGROUND

• Taira N. Nicorandil as a hybrid between nitrates and potassium channel activators. Am J Cardiol. 1989 Jun 20;63(21):18J-24J. doi: 10.1016/0002-9149(89)90200-2.

  PMID: 2525320 BACKGROUND

• Ota S, Nishikawa H, Takeuchi M, Nakajima K, Nakamura T, Okamoto S, Setsuda M, Makino K, Yamakado T, Nakano T. Impact of nicorandil to prevent reperfusion injury in patients with acute myocardial infarction: Sigmart Multicenter Angioplasty Revascularization Trial (SMART). Circ J. 2006 Sep;70(9):1099-104. doi: 10.1253/circj.70.1099.

  PMID: 16936418 BACKGROUND

• Tsubokawa A, Ueda K, Sakamoto H, Iwase T, Tamaki S. Effect of intracoronary nicorandil administration on preventing no-reflow/slow flow phenomenon during rotational atherectomy. Circ J. 2002 Dec;66(12):1119-23. doi: 10.1253/circj.66.1119.

  PMID: 12499617 BACKGROUND

• Lim SY, Bae EH, Jeong MH, Kang DG, Lee YS, Kim KH, Lee SH, Yoon KH, Hong SN, Park HW, Hong YJ, Kim JH, Kim W, Ahn YK, Cho JG, Park JC, Kang JC. Effect of combined intracoronary adenosine and nicorandil on no-reflow phenomenon during percutaneous coronary intervention. Circ J. 2004 Oct;68(10):928-32. doi: 10.1253/circj.68.928.

  PMID: 15459466 BACKGROUND

• Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, Tomoike H, Kitamura S; J-WIND investigators. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet. 2007 Oct 27;370(9597):1483-93. doi: 10.1016/S0140-6736(07)61634-1.

  PMID: 17964349 BACKGROUND

• Feng C, Liu Y, Wang L, Niu D, Han B. Effects of Early Intracoronary Administration of Nicorandil During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction. Heart Lung Circ. 2019 Jun;28(6):858-865. doi: 10.1016/j.hlc.2018.05.097. Epub 2018 May 22.

  PMID: 29891250 DERIVED

MeSH Terms

Conditions

Coronary Disease; ST Elevation Myocardial Infarction

Interventions

Nicorandil; Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Institute of Cardiovascular Disease Xuzhou Central Hospital

  Southeast University

  STUDY DIRECTOR

Central Study Contacts

Feng chunguang, PhD

CONTACT

+8618936376559; fcg999@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 6, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2016
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

CN (1)