drugset / Trial / NCT02435797
Effect of Nicorandil for the Patients of Acute ST Segment Elevation Myocardial Infarction
RandomizedParallel-groupSingle-blindPrevention
Summary
To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI) reduces reperfusion injury.
Timeline
- Start
- 2015-04
- Primary completion
- 2015-08
- Completion
- 2016-10
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nicorandil | Other / unclassified | 2 mg | Other |