A Phase 4 interventional study of Danlou Tablets and Placebo in Left Ventricular Remodeling and Acute Myocardial Infarction, sponsored by shuai Mao. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-05.
Sponsored by shuai Mao · Phase 4, Interventional, and Treatment
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.
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).
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 82 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →This is the only study on the registry with shuai Mao as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Danlou tablets (4.5 g oral dose taken once daily) for 90 days
Drug: Danlou Tablets
matching placebo for 90 days
Other: Placebo
Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
Also known as: Danlou
Placebo with no chemical effects.
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.
Time frame: 90 days
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.
Time frame: 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.
Time frame: 90 days
adverse events
Time frame: 180 days
Left ventricular Ejection Fraction from baseline to 90 days
Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography.
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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