Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction

NCT02524964 | Unknown Phase 4 DMC

• 1 other identifier: B2014-011-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Ventricular Remodeling; Acute Myocardial Infarction

Keywords

left ventricular remodeling; cardiac magnetic resonance imaging; acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• left ventricular end-diastolic volume index

  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 .

  6 months

Secondary Outcomes (7)

• cardiac magnetic resonance imaging measures of LV remolding

  6 months

• cardiac magnetic resonance imaging measures of microvascular obstruction

  6 months

• variation (change from baseline) of biomarkers indicating myocardial fibrosis

  6 months

• major adverse cardiac event

  1 and 6 months

• 6-minute walk test

  6 months

Study Arms (2)

sodium tanshinone IIA sulfonate

EXPERIMENTAL

sodium tanshinone IIA sulfonate (80 mg q.d. for 7 days)

Drug: sodium tanshinone IIA sulfonate

control

SHAM COMPARATOR

same volume/day of normal saline.

Other: control

Interventions

sodium tanshinone IIA sulfonate DRUG

eligible participants were randomized to receive sodium tanshinone IIA sulfonate injection (drip 80 mg/day for 7 days immediately after PCI)

Also known as: sodium tanshinone IIA sulfonate injection

sodium tanshinone IIA sulfonate

control OTHER

equivalent volume of sodium chloride solution

Also known as: sodium chloride solution

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or over and under 80 years;
• \. First-time myocardial infarction on admission;
• \. Presence of STEMI who has successfully coronary recanalization by PCI within 12 h after the symptom onset;
• \. Willingness to provide informed consent prior to enrollment;
• \. Patient is able to comply with all follow-up evaluation

You may not qualify if:

• \. Contraindications to performance of CMRI \[pacemakers, implantable cardioverter/defibrillator devices, cardiac resynchronization therapy (CRT), claustrophobia, metal implants (joint prosthesis, et al), history of penetrative eye lesion\];
• \. Previous myocardial infarction, arrhythmia (including atrial fibrillation or bundle brunch block), significant valvular disease, and hypertrophic cardiomyopathy;
• \. Severe heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤30%) or cardiogenic shock;
• \. Serious impairment of renal function (glomerular filtration rate ≤50 mL/min per 1.73 m2);
• \. Hypohepatia (elevated of alanine aminotransferase and aspartate aminotransferase serum levels);
• \. Severe coagulopathy prior to randomization;
• \. Malignant tumors or other life-threatening diseases with limited life expectancy \<1 year;
• \. Significant neuropsychopathic condition precluding written informed consent;
• \. Pregnant and lactating women;
• \. Known radiographic contrast or sodium tanshinone IIA sulfonate allergy;
• \. Be on therapy with immunosuppressants;
• \. Currently participated in any other investigational therapeutic or device trial;
• \. Clinical follow-up over the next half years not possible

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (2)

• He X, Yang F, Wu Y, Lu J, Gao X, Zhu X, Yang J, Liu S, Xiao G, Pan X. Identification of tanshinone I as cap-dependent endonuclease inhibitor with broad-spectrum antiviral effect. J Virol. 2023 Oct 31;97(10):e0079623. doi: 10.1128/jvi.00796-23. Epub 2023 Sep 21.

  PMID: 37732786 DERIVED

• Mao S, Li X, Wang L, Yang PC, Zhang M. Rationale and Design of Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (STAMP-REMODELING) Trial: A Randomized Controlled Study. Cardiovasc Drugs Ther. 2015 Dec;29(6):535-542. doi: 10.1007/s10557-015-6625-2.

  PMID: 26482376 DERIVED

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

tanshinone II A sodium sulfonate; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• minzhouzhang zhang, M.D.

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

shuai mao, M.D.

CONTACT

86-20-81887233; maoshuaitcm@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Critical Care Medicine

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)