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

NCT ID: NCT02524964

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-07-31

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.

Detailed Description

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 LVEDVi measured using cardiac MRI when compared to placebo.

Secondary endpoints will include cardiac MRI measures of variations in microvascular obstruction, defect size, ventricular wall motion score, wall thickening, global LV ejection fraction, ventricular volumes (LV end-systolic/ diastolic volume) and myocardial perfusion during the same interval.

Furthermore, the investigators will determine the variation (change from baseline) of biomarkers indicating myocardial fibrosis (PICP, PIIINP, ICTP and MMPs) and NT-ProBNP at 1 and 6 months after AMI.

Additional efficacy endpoints will include 6-minute walk test, New York Heart Association functional classification, Seattle Angina Questionnaire score and incidence of cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization) at the 6-month follow-up will also be analyzed to evaluate the efficacy of sodium tanshinone IIA sulfonate treatment.

Conditions

Left Ventricular Remodeling; Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

sodium tanshinone IIA sulfonate

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

Group Type: EXPERIMENTAL

sodium tanshinone IIA sulfonate

Intervention Type: DRUG

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

control

same volume/day of normal saline.

Group Type: SHAM_COMPARATOR

control

Intervention Type: OTHER

equivalent volume of sodium chloride solution

Interventions

sodium tanshinone IIA sulfonate

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

Intervention Type: DRUG

control

equivalent volume of sodium chloride solution

Intervention Type: OTHER

Other Intervention Names

sodium tanshinone IIA sulfonate injection; sodium chloride solution

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 1. 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];
• 2. Previous myocardial infarction, arrhythmia (including atrial fibrillation or bundle brunch block), significant valvular disease, and hypertrophic cardiomyopathy;
• 3. Severe heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤30%) or cardiogenic shock;
• 4. Serious impairment of renal function (glomerular filtration rate ≤50 mL/min per 1.73 m2);
• 5. Hypohepatia (elevated of alanine aminotransferase and aspartate aminotransferase serum levels);
• 6. Severe coagulopathy prior to randomization;
• 7. Malignant tumors or other life-threatening diseases with limited life expectancy <1 year;
• 8. Significant neuropsychopathic condition precluding written informed consent;
• 9. Pregnant and lactating women;
• 10. Known radiographic contrast or sodium tanshinone IIA sulfonate allergy;
• 11. Be on therapy with immunosuppressants;
• 12. Currently participated in any other investigational therapeutic or device trial;
• 13. Clinical follow-up over the next half years not possible

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

shuai Mao

Department of Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

minzhouzhang zhang, M.D.

Role: STUDY_DIRECTOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

shuai mao, M.D.

Role: CONTACT

maoshuaitcm@hotmail.com

86-20-81887233 ext. 32808

Facility Contacts

Minzhou Zhang, Dr.

Role: primary

minzhouzhang@yeah.net

86-20-81887233 ext. 32801

Liheng Guo, Dr.

Role: backup

lihengguo1@yeah.net

86-8187236 ext. 32907

References

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.

Reference Type: DERIVED

PMID: 37732786 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26482376 (View on PubMed)

Other Identifiers

B2014-011-01

Identifier Type: -

Identifier Source: org_study_id