Clinical trial NCT02874287: Efficacy Study of Hydroxychloroquine to Treat High-risk Coronary Artery Disease.
Official title: Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Hydroxychloroquine
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of fasting high sensitivity C-reactive protein
timeFrame: change from baseline at the 16th week, 39th week, 55th week.
Secondary outcomes:
measure: change of blood pressure
timeFrame: change from baseline at the 12th week, 20th week.
measure: change of fasting blood lipid
timeFrame: change from baseline at the 12th week, 20th week.
measure: change of fasting blood glucose
timeFrame: change from baseline at the 12th week, 20th week.
measure: change of fasting insulin
timeFrame: change from baseline at the 12th week, 20th week.
measure: change of echocardiogram
timeFrame: change from baseline at the 12th week, 20th week.
measure: change of fasting Interleukin 6
timeFrame: change from baseline at the 12th week, 20th week.
measure: change of fasting tumor necrosis factor
timeFrame: change from baseline at the 12th week, 20th week.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yue Wu, Professor
role: STUDY_DIRECTOR
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