NCT02524964

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

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: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-01
• Completion: 2017-07-01
• First posted: 2015-08-17
• Last updated: 2016-09-01

Locations

1 site across 1 country: China