NCT02850627

Brief Summary

The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

July 21, 2016

Last Update Submit

July 31, 2016

Conditions

Coronary Heart DiseaseAcute Myocardial Infarction

Keywords

acute coronary syndromeTongguan capsulemiRNAs

Outcome Measures

Primary Outcomes (1)

  • miRNAs spectrum

    Test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.

    six months

Secondary Outcomes (12)

  • major adverse cardiac event

    six months

  • Renin predicts cardiovascular homeostasis and ventricular remodeling

    6 months

  • Ang II predicts cardiovascular homeostasis and ventricular remodeling

    6 months

  • Serum E

    6 months

  • Inflammatory mediators

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Tongguan capsule

EXPERIMENTAL

Tongguan capsule (0.5 g tid. for 6 months)

Drug: Tongguan capsule

placebo capsule

PLACEBO COMPARATOR

same volume/day of placebo capsule (0.5 g tid. for 6 months)

Drug: placebo capsule

Interventions

Tongguan capsuleDRUG

eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)

Tongguan capsule
placebo capsuleDRUG

eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)

placebo capsule

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful
  • Postoperative routine drug treatment
  • Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
  • Aged 35 to 75 years old
  • Must sign a consent form.

You may not qualify if:

  • Renal insufficiency, the male serum creatinine \> 2.5 mg/dl (\> 220 umo/l), women \> 2.0 mg/dl (\> 175 umo/l)
  • With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
  • Serious cardiac insufficiency (EF \< 35%)
  • Uncontrolled patients with high blood pressure
  • Merger or severe valvular heart disease in acute cerebrovascular disease
  • Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
  • Patients with severe mental illness
  • Patients with malignant tumor or life expectancy in less than three years
  • Patients with severe hematopoietic system disease
  • Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
  • Pregnancy or ready to pregnant women, nursing mothers;
  • Participated in nearly three months, or is in other clinical subjects . -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseAcute Coronary Syndrome

Interventions

tongguan

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Minzhou Zhang, MD

    Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

    STUDY DIRECTOR

  • Huizheng Zhu, PhD

    Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huizheng Zhu, PHD

CONTACT

86-20-81887233754357604@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 1, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

August 2, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)