title: The Effect of Sodium Tanshinone IIA Sulfate and Simvastatin on Elevated Serum Levels of Inflammatory Markers in Patients with Coronary Heart Disease: A Study Protocol for a Randomized Controlled Trial.
abstract: Background. Coronary heart disease (CHD) due to atherosclerotic inflammation remains a significant threat to global health despite the success of the lipid-lowering, anti-inflammatory statins. Tanshinone IIA, a potent anti-inflammatory compound derived from Traditional Chinese Medicine (TCM), may be able to supplement statins by further reducing levels of circulating inflammatory markers correlated to cardiovascular risk. Here, we present the protocol of a randomized controlled trial (RCT) that will investigate the synergistic effect of sodium tanshinone IIA sulfate and simvastatin on reducing elevated inflammatory markers in patients with CHD.
  
  
  METHODS
  Seventy-two inpatients with confirmed CHD, elevated serum high-sensitivity C-reactive protein (Hs-CRP) level, and a TCM diagnosis of blood stasis syndrome will be enrolled and randomized 1 : 1 into the control or experimental group. Intervention. All subjects will receive a standard Western therapy including 20 mg simvastatin orally once per evening. Patients in the experimental group will additionally receive a daily 80 mg dose of sodium tanshinone IIA sulfate intravenously, diluted into 250 mL 0.9% NaCl solution. The treatment period will be 14 days. Outcomes. Primary outcome parameter: serum Hs-CRP level. Secondary outcome parameters: other circulating inflammatory markers (including IL-6, TNF α , VCAM-1, CD40, sCD40L, MCP-1, and MMP-9), improvement in symptoms of angina and blood stasis syndrome, and safety. This trial is registered with ChiCTR-TRC-12002361.
authors: Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China ; Department of Cardiovascular Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.
authors: Qinghua
authors: Q
authors: Shang
authors: Hanjay
authors: H
authors: Wang
authors: Siming
authors: S
authors: Li
authors: Hao
authors: H
authors: Xu
references: Circulation. 1996 Nov 15;94(10):2373-80
references: 8921776
references: Circ Res. 2002 Aug 23;91(4):281-91
references: 12193460
references: Circulation. 1979 Mar;59(3):607-9
references: 761341
references: Circ Res. 1997 Sep;81(3):448-54
references: 9285647
references: Acta Physiol Scand. 2001 Sep;173(1):35-43
references: 11678724
references: N Engl J Med. 2008 Nov 20;359(21):2195-207
references: 18997196
references: JAMA. 2001 Jul 4;286(1):64-70
references: 11434828
references: J Clin Invest. 1990 Apr;85(4):1260-6
references: 2318980
references: Am J Cardiol. 2005 Aug 1;96(3):339-45
references: 16054454
references: Arterioscler Thromb. 1991 Nov-Dec;11(6):1795-805
references: 1931881
references: Drugs. 2004;64(11):1181-96
references: 15161326
references: BMJ. 2003 Jun 28;326(7404):1423
references: 12829554
references: Am J Cardiovasc Drugs. 2001;1(6):411-20
references: 14728000
references: Proc Natl Acad Sci U S A. 1990 Jul;87(13):5134-8
references: 1695010
references: N Engl J Med. 2005 Apr 21;352(16):1685-95
references: 15843671
references: Clin Chem. 2008 Jan;54(1):24-38
references: 18160725
references: N Engl J Med. 1997 Apr 3;336(14):973-9
references: 9077376
references: J Lipid Res. 2005 Jun;46(6):1081-92
references: 15834121
references: Cardiovasc Res. 2006 Jul 1;71(1):30-9
references: 16624260
references: J Ethnopharmacol. 2012 Jun 1;141(2):578-83
references: 21924336
references: Proc Natl Acad Sci U S A. 1979 Jan;76(1):333-7
references: 218198
references: Atherosclerosis. 2012 Jan;220(1):3-10
references: 21774934
references: Proc Natl Acad Sci U S A. 1989 Feb;86(4):1372-6
references: 2465552
references: J Zhejiang Univ Sci B. 2005 Nov;6(11):1045-56
references: 16252337
references: Circulation. 1996 Sep 1;94(5):874-7
references: 8790019
references: Evid Based Complement Alternat Med. 2012;2012:715790
references: 22548119
references: N Engl J Med. 2004 Apr 8;350(15):1495-504
references: 15007110