Danlou Tablets to Prevent Left Ventricular Remodeling

February 4, 2016 updated by: shuai Mao

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

shuai Mao

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangdongPHTCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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