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Completed

NCT Number: NCT02874287

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Hydroxychloroquine Sulfate Tablets

Drug

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

Placebo tablets

Drug

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

Primary outcomes

  1. change of fasting high sensitivity C-reactive protein

    Time frame: change from baseline at the 16th week, 39th week, 55th week.

Secondary outcomes

  1. change of blood pressure

    Time frame: change from baseline at the 12th week, 20th week.

  2. change of fasting blood lipid

    Time frame: change from baseline at the 12th week, 20th week.

  3. change of fasting blood glucose

    Time frame: change from baseline at the 12th week, 20th week.

  4. change of fasting insulin

    Time frame: change from baseline at the 12th week, 20th week.

  5. change of echocardiogram

    Time frame: change from baseline at the 12th week, 20th week.

  6. change of fasting Interleukin 6

    Time frame: change from baseline at the 12th week, 20th week.

  7. change of fasting tumor necrosis factor

    Time frame: change from baseline at the 12th week, 20th week.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: CHANGAN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2016
Registry last updated
Aug 27, 2021

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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