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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02524964
• Other study ID #: B2014-011-01
• Status: Recruiting
• Phase: Phase 4
• First received: August 10, 2015
• Last updated: August 31, 2016
• Start date: December 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: shuai mao, M.D.
• Phone: 86-20-81887233
• Email: maoshuaitcm[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Tianjin Institute of Clinical Evaluation for Chinese MedicineChina: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Left Ventricular Remodeling
• Myocardial Infarction
• Ventricular Remodeling

Intervention

Drug:
• 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)

Other:
• control
equivalent volume of sodium chloride solution

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	cardiac magnetic resonance imaging measures of LV remolding	cardiac magnetic resonance imaging measures of variations in left ventricular end-systolic/ diastolic volume (mL) during the same interval.	6 months	No
Secondary	cardiac magnetic resonance imaging measures of microvascular obstruction	cardiac magnetic resonance imaging measures of the frequency of delayed or absent wash-in of contrast agent into the infarct zone.	6 months	No
Secondary	variation (change from baseline) of biomarkers indicating myocardial fibrosis	type 1 collagen telopeptide (ng/mL), aminoterminal propeptide of type I procollagen (ng/mL), aminoterminal propeptide of type III procollagen (ng/mL), matrix metalloproteinase2 (ng/mL), matrix metalloproteinase9 (ng/mL) at 1 and 6 months after AMI.	6 months	No
Secondary	major adverse cardiac event	frequency of the reported 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)	1 and 6 months	Yes
Secondary	6-minute walk test	A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)	6 months	Yes
Secondary	New York Heart Association functional classification	I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc.; II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.; III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.; IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.	6 months	Yes
Secondary	Seattle Angina Questionnaire score	The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception). (in Units on a Scale).	6 months	Yes