Rationale and Design of Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (STAMP-REMODELING) Trial: A Randomized Controlled Study.
BACKGROUND
Left ventricular (LV) remodeling in ischemic cardiomyopathy is the leading cause of heart failure and is an established prognostic factor for adverse cardiovascular events. Experimental studies suggest that sodium tanshinone IIA sulfonate attenuates cardiac remodeling in animal models of acute myocardial infarction (AMI). However, the effects of this drug in the clinical setting remain unclear. Therefore, the STAMP-REMODELING trial is set up to investigate whether treatment with sodium tanshinone IIA sulfonate would prevent the maladaptive progression to adverse LV remodeling in patients following ST-segment elevation myocardial infarction (STEMI).


METHODS
Approximately 80 patients with STEMI successfully treated with primary percutaneous coronary intervention (PCI) will be enrolled and randomized to receive sodium tanshinone IIA sulfonate (80 mg q.d. for 7 days) in addition to standard therapy or the same volume of hydration per day. The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed with cardiac magnetic resonance imaging (CMR) at baseline and 6 months.


CONCLUSIONS
This study will provide important clinical evidence on the efficacy of sodium tanshinone IIA sulfonate treatment in patients with STEMI when used in combination with current therapies that may significantly reduce adverse LV remodeling and potentially improve clinical outcomes.


BACKGROUND
Clinical Trials.gov: NCT02524964.
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Shuai
S
Mao
School of Chemistry & Molecular Biosciences, The University of Queensland, Brisbane, 4072, Australia.
Xiaotong
X
Li
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Lei
L
Wang
Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA.
Phillip C
PC
Yang
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. minzhouzhang@yeah.net.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. minzhouzhang@yeah.net.
Minzhou
M
Zhang
Cardiac magnetic resonance imaging; Left ventricular remodeling; Myocardial infarction; Sodium tanshinone IIA sulfonate