Danlou Tablets to Prevent Left Ventricular Remodeling

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675322
• Other study ID #: GuangdongPHTCM
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2016
• Last updated: February 4, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Danlou Tablets
Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).

Other:
• Placebo
Placebo with no chemical effects.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
shuai Mao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	adverse events		180 days
Secondary	Left ventricular Ejection Fraction from baseline to 90 days	Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography.	90 days