Acute Myocardial Infarction, Left Ventricular Remodeling
Conditions
Brief summary
Danlou tablets are Chinese patent medicine which has been approved in China for the treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling remains unclear. This pilot study was designed to determine whether Danlou tablets reduced adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI). Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI. Major end points were changes in LV volumes and ejection fractions as evaluated by serial echocardiography in addition to clinical outcomes were also determined.
Detailed description
This randomized, prospective, double-blind, placebo-controlled, parallel-group clinical trial was performed in two institutions (Guangdong Provincial Hospital of CM and Wuyi Hospital of CM). The study was conducted in accordance with the Declaration of Helsinki and its text revisions and all participants provided written informed consent before enrollment. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (B2011-41-01). Once eligible candidates had undergone PCI, they were admitted to the coronary intensive care unit and received standard treatment according to the institutional protocol based on American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines.20 Simultaneously, patients were randomized assigned in a 1:1 ratio to receive Danlou tablets (4.5 g oral dose taken once daily) or matching placebo for 90 days according to a computer-generated site-stratified, block randomization schedule. Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
Interventions
DRUGDanlou Tablets
Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
OTHERPlacebo
Placebo with no chemical effects.
Sponsors
shuai Mao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* acute myocardial infarction * successfully underwent revascularization
Exclusion criteria
* previous myocardial infarction within 30 days * malignant arrhythmia * congenital heart disease * cardiac shock * documented or suspected history of heart failure or depressed LV ejection fraction \<15% * planned coronary artery bypass grafting * a life expectancy of \<1 year * hepatic impairment * glomerular filtration rate ≤30 mL/min per 1.73 m2 * autoimmune or connective tissue disease * chronic substance abuse or psychiatric illness * unable to complete 3 month clinical follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days | 90 days | Left Ventricular End Diastolic Volume Index (LVEDVi) measured by two-dimensional echocardiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in Left ventricular End Systolic Volume Index from baseline to 90 days | 90 days | Left Ventricular End Systolic Volume Index (LVESVi) measured by two-dimensional echocardiography. |
| Major adverse cardiovascular events | 90 days | Major adverse cardiovascular events includes cardiac death, cardiac shock, myocardial infarction, documented unstable angina requiring revascularization (bypass surgery or repeat PCI), severe angina or severe heart failure. |
| adverse events | 180 days | — |
| Left ventricular Ejection Fraction from baseline to 90 days | 90 days | Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography. |
Outcome results
None listed