NCT02675322

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

February 1, 2016

Last Update Submit

February 4, 2016

Conditions

Left Ventricular RemodelingAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • changes in Left ventricular End Systolic Volume Index from baseline to 90 days

    90 days

  • Major adverse cardiovascular events

    90 days

  • adverse events

    180 days

  • Left ventricular Ejection Fraction from baseline to 90 days

    90 days

Study Arms (2)

Danlou Tablets

EXPERIMENTAL

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

Drug: Danlou Tablets

placebo

PLACEBO COMPARATOR

matching placebo for 90 days

Other: Placebo

Interventions

Danlou TabletsDRUG

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

Also known as: Danlou
Danlou Tablets
PlaceboOTHER

Placebo with no chemical effects.

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute myocardial infarction
  • successfully underwent revascularization

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mao S, Wang L, Ouyang W, Zhou Y, Qi J, Guo L, Zhang M, Hinek A. Traditional Chinese medicine, Danlou tablets alleviate adverse left ventricular remodeling after myocardial infarction: results of a double-blind, randomized, placebo-controlled, pilot study. BMC Complement Altern Med. 2016 Nov 8;16(1):447. doi: 10.1186/s12906-016-1406-4.

    PMID: 27825334DERIVED

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

danlou tablet

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • minzhou zhang, M.D.

    Heart Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Guangdong Provincial Hospital of Traditional Chinese Medicine

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 5, 2016

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share