Danlou Tablets to Prevent Left Ventricular Remodeling

Sponsor

shuai Mao (Other)

Overall Status

Completed

CT.gov ID

NCT02675322

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Remodeling Acute Myocardial Infarction	Drug: Danlou Tablets Other: Placebo	Phase 4

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Danlou Tablets

Danlou tablets (4.5 g oral dose taken once daily) for 90 days

Drug: Danlou Tablets

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

Other Names:

Danlou

Placebo Comparator: placebo

matching placebo for 90 days

Other: Placebo

Placebo with no chemical effects.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

shuai Mao

Investigators

Study Chair: minzhou zhang, M.D., Heart Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT02675322

Other Study ID Numbers:

GuangdongPHTCM

First Posted:

Feb 5, 2016

Last Update Posted:

Feb 5, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Myocardial Infarction

Infarction

Ventricular Remodeling

Study Results

No Results Posted as of Feb 5, 2016