Efficacy Study of Hydroxychloroquine to Treat High-risk Coronary Artery Disease. (CHANGAN)

August 26, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.

The purpose of this study is to evaluate whether treated with hydroxychloroquine could improve therapeutic effect for patients with high-risk coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This double blind, placebo, randomized controlled trial is going to assess if hydroxychloroquine could improve the high sensitivity C-reaction protein, blood lipid, blood glucose and blood pressure, also whether hydroxychloroquine could affect the secretion of inflammatory cytokines and the M1/M2 phenotype polarization of macrophages in patients with high-risk coronary artery disease.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China
        • First Affiliated Hospital of Xi'an JiaoTong University

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients have been diagnosed coronary artery disease by coronary angiography or CT angiography.
  • coronary artery disease with hypertension or diabetes or hyperlipidaemia(LDL>1.8mmol/L)
  • High sensitivity C-reactive protein >1mg/L.
  • On guideline-based secondary prevention of coronary heart disease medications≥1 months.
  • No use of steroids, antibiotics, immunosuppressors a week before treatment.

Exclusion Criteria:

  • Retinal disease.
  • Chronic hepatopathy(ALT>120U/L).
  • Renal dysfunction (eGFR<60).
  • Moderately severe anemia, thrombocytopenia and leukocytopenia.
  • Other contraindications for hydroxychloroquine.
  • Active hemorrhage.
  • Cancer or life expectancy< a year.
  • New York Heart Association (NYHA) functional class≥class III, Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting in plan.
  • Pregnancy and lactation.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hydroxychloroquine
Subjects are treated with hydroxychloroquine sulfate tablets.All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Drug: Hydroxychloroquine Sulfate Tablets
Subjects are treated with oral hydroxychloroquine sulfate tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.
Other Names:
  • Plaquenil
Other: placebo
Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Drug: Placebo Tablets
Subjects are treated with oral placebo tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of fasting high sensitivity C-reactive protein
Time Frame: change from baseline at the 16th week, 39th week, 55th week.
change from baseline at the 16th week, 39th week, 55th week.

Secondary Outcome Measures

Outcome Measure
Time Frame
change of blood pressure
Time Frame: change from baseline at the 12th week, 20th week.
change from baseline at the 12th week, 20th week.
change of fasting blood lipid
Time Frame: change from baseline at the 12th week, 20th week.
change from baseline at the 12th week, 20th week.
change of fasting blood glucose
Time Frame: change from baseline at the 12th week, 20th week.
change from baseline at the 12th week, 20th week.
change of fasting insulin
Time Frame: change from baseline at the 12th week, 20th week.
change from baseline at the 12th week, 20th week.
change of echocardiogram
Time Frame: change from baseline at the 12th week, 20th week.
change from baseline at the 12th week, 20th week.
change of fasting Interleukin 6
Time Frame: change from baseline at the 12th week, 20th week.
change from baseline at the 12th week, 20th week.
change of fasting tumor necrosis factor
Time Frame: change from baseline at the 12th week, 20th week.
change from baseline at the 12th week, 20th week.

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: Yue Wu, Professor, First Affiliated Hospital Xi'an Jiaotong University

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 (Actual)

October 8, 2017

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRS-2016-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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