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Completed

NCT Number: NCT02675322

Danlou Tablets to Prevent Left Ventricular Remodeling

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.

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Key information

Conditions

Left Ventricular Remodeling Acute Myocardial Infarction Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventricular Remodeling

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danlou Tablets

Drug

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

Other names: Danlou

Placebo

Other

Placebo with no chemical effects.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. adverse events

    Time frame: 180 days

  4. Left ventricular Ejection Fraction from baseline to 90 days

    Time frame: 90 days

    Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography.

Sponsors and collaborators

Lead sponsor

shuai Mao

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2016
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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