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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02874287

Acronym

CHANGAN

Enrollment

Registered

2016-08-22

Start date

2017-10-08

Completion date

2019-06-01

Last updated

2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease, Hydroxychloroquine

Brief summary

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

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.

Interventions

DRUGHydroxychloroquine 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.

DRUGPlacebo 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026