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. Participants: 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, TNFα, 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.
Highlights
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
Despite recent advances in the treatment and prevention of cardiovascular diseases, CHD remains a significant threat to global health
The multinational JUPITER trial, clearly demonstrated that patients with healthy low-density lipoprotein cholesterol (LDL-C) levels according to standard guidelines may still be at elevated risk due to inflammation associated with atherosclerosis, as measured by high-sensitivity CRP (hsCRP) [19]
Summary
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. Secondary outcome parameters: other circulating inflammatory markers (including IL-6, TNFα, VCAM-1, CD40, sCD40L, MCP-1, and MMP-9), improvement in symptoms of angina and blood stasis syndrome, and safety. The formation of atherosclerotic plaque is an inflammatory response, usually associated with elevated levels of low-density lipoprotein cholesterol (LDL-C) in the blood [2] To this end, statins have served as a notably successful pharmacologic intervention against CHD from the standpoint of Western medicine. As demonstrated by the PRINCE study, statins moderate the atherosclerotic inflammatory response by reducing levels of C-reactive protein (CRP) [4], a robust marker of systemic inflammation whose concentration in the blood strongly correlates with the patient’s cardiovascular risk [5].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
