Danlou Tablets to Prevent Left Ventricular Remodeling

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effects of Danlou Tablets to Prevent Left Ventricular Remodeling After Myocardial Infarction: A Double-blind, Randomized, Placebo Controlled, Pilot Study

Conditions
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Left Ventricular Remodeling, Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Danlou Tablets
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danlou Tablets<br>Danlou tablets (4.5 g oral dose taken once daily) for 90 days | Drug: Danlou Tablets<br>* Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).<br>* Other names: Danlou;|
| Placebo Comparator: placebo<br>matching placebo for 90 days | Other: Placebo<br>* Placebo with no chemical effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days | Left Ventricular End Diastolic Volume Index (LVEDVi) measured by two-dimensional echocardiography. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Left ventricular End Systolic Volume Index from baseline to 90 days | Left Ventricular End Systolic Volume Index (LVESVi) measured by two-dimensional echocardiography. | 90 days | 
| Major adverse cardiovascular events | 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. | 90 days | 
| adverse events |  | 180 days | 
| Left ventricular Ejection Fraction from baseline to 90 days | Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography. | 90 days |