NCT02524964

Effects of Sodium Tanshinone IIA Sulfonate on Left Ventricular Remodeling in Patients With ST-segment Elevation Myocardial Infarction Following Percutaneous Coronary Intervention

Status unknown Phase 4 Last updated 31 August 2016

What this trial tests

Phase 4 trial testing sodium tanshinone IIA sulfonate in Left Ventricular Remodeling in 60 participants. Status unknown.

Timeline

1 December 2015

Primary endpoint
1 December 2016

1 July 2017

Quick facts

Lead sponsor	Guangdong Provincial Hospital of Traditional Chinese Medicine
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	60
Start date	1 December 2015
Primary completion	1 December 2016
Estimated completion	1 July 2017
Sites	1 location across China

Drugs / interventions tested

• sodium tanshinone IIA sulfonate — full drug profile →
• control

Conditions studied

• Left Ventricular Remodeling — all drugs for Left Ventricular Remodeling →
• Acute Myocardial Infarction — all drugs for Acute Myocardial Infarction →

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Who can join

Adults 18 to 80, any sex, with Left Ventricular Remodeling or Acute Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• left ventricular end-diastolic volume index
  Time frame: 6 months
  The primary endpoint is to determine whether sodium tanshinone IIA sulfonate could prevent LV remodeling among patients with completely reperfused AMI after PCI, detected by 6 month change in left ventricular end-diastolic volume index (mL/m\^2) measured using cardiac magnetic resonance imaging .

Sponsor's own description

Approximately 60 patients with ST-segment elevation myocardial infarction successfully treated with primary percutaneous coronary intervention will be enrolled and randomized to receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same volume/day of normal saline.

The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed with cardiac magnetic resonance imaging (MRI) at baseline and 6 months.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ferroptosis-modulating small molecules for targeting drug-resistant cancer: Challenges and opportunities in manipulating redox signaling.
   Koeberle SC, Kipp AP, Stuppner H, Koeberle A. · · 2023 · cited 74× · PMID 36658724 · DOI 10.1002/med.21933
2. Sodium tanshinone IIA sulfonate prevents the adverse left ventricular remodelling: Focus on polymorphonuclear neutrophil-derived granule components.
   Mao S, Taylor S, Chen Q, Zhang M, et al · · 2019 · cited 26× · PMID 31066232 · DOI 10.1111/jcmm.14306
3. Rationale and Design of Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (STAMP-REMODELING) Trial: A Randomized Controlled Study.
   Mao S, Li X, Wang L, Yang PC, et al · · 2015 · cited 19× · PMID 26482376 · DOI 10.1007/s10557-015-6625-2
4. The Skeletal Effects of Tanshinones: A Review.
   Ekeuku SO, Pang KL, Chin KY. · · 2021 · cited 14× · PMID 33923673 · DOI 10.3390/molecules26082319
5. Identification of tanshinone I as cap-dependent endonuclease inhibitor with broad-spectrum antiviral effect.
   He X, Yang F, Wu Y, Lu J, et al · · 2023 · cited 7× · PMID 37732786 · DOI 10.1128/jvi.00796-23
6. Aurora kinases signaling in cancer: from molecular perception to targeted therapies.
   Vats P, Saini C, Baweja B, Srivastava SK, et al · · 2025 · cited 6× · PMID 40533769 · DOI 10.1186/s12943-025-02353-3
7. AFC1 Compound Attenuated MI/R-Induced Ventricular Remodeling <i>via</i> Inhibiting PDGFR and STAT Pathway.
   Liu J, Zhou X, Meng Q, Huang KW, et al · · 2019 · cited 3× · PMID 31680946 · DOI 10.3389/fphar.2019.01142
8. Computational drug screening against the SARS-CoV-2 Saudi Arabia isolates through a multiple-sequence alignment approach.
   Mok PL, Koh AE, Farhana A, Alsrhani A, et al · · 2021 · PMID 33551661 · DOI 10.1016/j.sjbs.2021.01.051