Early Vascular Healing in Acute Coronary Syndrome Patients With Different Doses of Rosuvastatin

Summary

This is a prospective, randomized trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. Through the study, the investigators aim to evaluate the effects of high dose rosuvastatin calcium on "target vessel" endothelialization and "non-target vessel" plaque stability. Moreover, the investigators may provide mechanically evidence of clinical application of high dose rosuvastatin in patients with acute coronary syndrome.

Timeline

Start

2016-07

Primary completion

2017-12

Completion

2019-12

Publications

• Background Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol. 2007 Oct 2;50(14):1299-304. doi: 10.1016/j.jacc.2007.06.029. Epub 2007 Sep 17.
• Background Grech ED. ABC of interventional cardiology: percutaneous coronary intervention. I: history and development. BMJ. 2003 May 17;326(7398):1080-2. doi: 10.1136/bmj.326.7398.1080. No abstract available.
• Background Gottsauner-Wolf M, Zasmeta G, Hornykewycz S, Nikfardjam M, Stepan E, Wexberg P, Zorn G, Glogar D, Probst P, Maurer G, Huber K. Plasma levels of C-reactive protein after coronary stent implantation. Eur Heart J. 2000 Jul;21(14):1152-8. doi: 10.1053/euhj.1999.1987.
• Background Walter DH, Fichtlscherer S, Britten MB, Rosin P, Auch-Schwelk W, Schachinger V, Zeiher AM. Statin therapy, inflammation and recurrent coronary events in patients following coronary stent implantation. J Am Coll Cardiol. 2001 Dec;38(7):2006-12. doi: 10.1016/s0735-1097(01)01662-x.
• Background Losordo DW, Isner JM, Diaz-Sandoval LJ. Endothelial recovery: the next target in restenosis prevention. Circulation. 2003 Jun 3;107(21):2635-7. doi: 10.1161/01.CIR.0000071083.31270.C3. No abstract available.
• Background Komatsu R, Ueda M, Naruko T, Kojima A, Becker AE. Neointimal tissue response at sites of coronary stenting in humans: macroscopic, histological, and immunohistochemical analyses. Circulation. 1998 Jul 21;98(3):224-33. doi: 10.1161/01.cir.98.3.224.
• Background Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation. 2010 Mar 9;121(9):1069-77. doi: 10.1161/CIRCULATIONAHA.109.906479. Epub 2010 Feb 22.
• Background Cholesterol Treatment Trialists' (CTT) Collaborators; Kearney PM, Blackwell L, Collins R, Keech A, Simes J, Peto R, Armitage J, Baigent C. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008 Jan 12;371(9607):117-25. doi: 10.1016/S0140-6736(08)60104-X.
• Background Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
• Background Cholesterol Treatment Trialists' (CTT) Collaborators; Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, Voysey M, Gray A, Collins R, Baigent C. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012 Aug 11;380(9841):581-90. doi: 10.1016/S0140-6736(12)60367-5. Epub 2012 May 17.
• Background Brugts JJ, Yetgin T, Hoeks SE, Gotto AM, Shepherd J, Westendorp RG, de Craen AJ, Knopp RH, Nakamura H, Ridker P, van Domburg R, Deckers JW. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials. BMJ. 2009 Jun 30;338:b2376. doi: 10.1136/bmj.b2376.
• Background Hou W, Lv J, Perkovic V, Yang L, Zhao N, Jardine MJ, Cass A, Zhang H, Wang H. Effect of statin therapy on cardiovascular and renal outcomes in patients with chronic kidney disease: a systematic review and meta-analysis. Eur Heart J. 2013 Jun;34(24):1807-17. doi: 10.1093/eurheartj/eht065. Epub 2013 Mar 6.
• Background Ray KK, Cannon CP, Ganz P. Beyond lipid lowering: What have we learned about the benefits of statins from the acute coronary syndromes trials? Am J Cardiol. 2006 Dec 4;98(11A):18P-25P. doi: 10.1016/j.amjcard.2006.09.016. Epub 2006 Sep 29.
• Background Almuti K, Rimawi R, Spevack D, Ostfeld RJ. Effects of statins beyond lipid lowering: potential for clinical benefits. Int J Cardiol. 2006 Apr 28;109(1):7-15. doi: 10.1016/j.ijcard.2005.05.056. Epub 2005 Jul 28.
• Background Liu T, Li L, Korantzopoulos P, Liu E, Li G. Statin use and development of atrial fibrillation: a systematic review and meta-analysis of randomized clinical trials and observational studies. Int J Cardiol. 2008 May 23;126(2):160-70. doi: 10.1016/j.ijcard.2007.07.137. Epub 2007 Nov 26.
• Background Marui N, Offermann MK, Swerlick R, Kunsch C, Rosen CA, Ahmad M, Alexander RW, Medford RM. Vascular cell adhesion molecule-1 (VCAM-1) gene transcription and expression are regulated through an antioxidant-sensitive mechanism in human vascular endothelial cells. J Clin Invest. 1993 Oct;92(4):1866-74. doi: 10.1172/JCI116778.
• Background Karalis IK, Bergheanu SC, Wolterbeek R, Dallinga-Thie GM, Hattori H, van Tol A, Liem AH, Wouter Jukema J. Effect of increasing doses of Rosuvastatin and Atorvastatin on apolipoproteins, enzymes and lipid transfer proteins involved in lipoprotein metabolism and inflammatory parameters. Curr Med Res Opin. 2010 Oct;26(10):2301-13. doi: 10.1185/03007995.2010.509264.
• Background Kleemann R, Princen HM, Emeis JJ, Jukema JW, Fontijn RD, Horrevoets AJ, Kooistra T, Havekes LM. Rosuvastatin reduces atherosclerosis development beyond and independent of its plasma cholesterol-lowering effect in APOE*3-Leiden transgenic mice: evidence for antiinflammatory effects of rosuvastatin. Circulation. 2003 Sep 16;108(11):1368-74. doi: 10.1161/01.CIR.0000086460.55494.AF. Epub 2003 Aug 25.
• Background Llevadot J, Murasawa S, Kureishi Y, Uchida S, Masuda H, Kawamoto A, Walsh K, Isner JM, Asahara T. HMG-CoA reductase inhibitor mobilizes bone marrow--derived endothelial progenitor cells. J Clin Invest. 2001 Aug;108(3):399-405. doi: 10.1172/JCI13131.
• Background Weber C, Erl W, Weber KS, Weber PC. HMG-CoA reductase inhibitors decrease CD11b expression and CD11b-dependent adhesion of monocytes to endothelium and reduce increased adhesiveness of monocytes isolated from patients with hypercholesterolemia. J Am Coll Cardiol. 1997 Nov 1;30(5):1212-7. doi: 10.1016/s0735-1097(97)00324-0.
• Background Mizukoshi M, Imanishi T, Tanaka A, Kubo T, Liu Y, Takarada S, Kitabata H, Tanimoto T, Komukai K, Ishibashi K, Akasaka T. Clinical classification and plaque morphology determined by optical coherence tomography in unstable angina pectoris. Am J Cardiol. 2010 Aug 1;106(3):323-8. doi: 10.1016/j.amjcard.2010.03.027.
• Background Akasaka T, Kubo T, Mizukoshi M, Tanaka A, Kitabata H, Tanimoto T, Imanishi T. Pathophysiology of acute coronary syndrome assessed by optical coherence tomography. J Cardiol. 2010 Jul;56(1):8-14. doi: 10.1016/j.jjcc.2010.05.005. Epub 2010 Jun 15.
• Background Bezerra HG, Costa MA, Guagliumi G, Rollins AM, Simon DI. Intracoronary optical coherence tomography: a comprehensive review clinical and research applications. JACC Cardiovasc Interv. 2009 Nov;2(11):1035-46. doi: 10.1016/j.jcin.2009.06.019.
• Background Kubo T, Imanishi T, Kashiwagi M, Ikejima H, Tsujioka H, Kuroi A, Ishibashi K, Komukai K, Tanimoto T, Ino Y, Kitabata H, Takarada S, Tanaka A, Mizukoshi M, Akasaka T. Multiple coronary lesion instability in patients with acute myocardial infarction as determined by optical coherence tomography. Am J Cardiol. 2010 Feb 1;105(3):318-22. doi: 10.1016/j.amjcard.2009.09.032. Epub 2009 Dec 22.
• Background Kubo T, Imanishi T, Takarada S, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Kitabata H, Tsuda K, Tomobuchi Y, Akasaka T. Assessment of culprit lesion morphology in acute myocardial infarction: ability of optical coherence tomography compared with intravascular ultrasound and coronary angioscopy. J Am Coll Cardiol. 2007 Sep 4;50(10):933-9. doi: 10.1016/j.jacc.2007.04.082. Epub 2007 Aug 20.

Drugs

Indications