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

Xi'an Jiaotong University

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Hydroxychloroquine Sulfate Tablets; Drug: Placebo Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT02874287

XJTU1AF-CRS-2016-011

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Hydroxychloroquine

Other group

Description:

Subjects are treated with hydroxychloroquine sulfate tablets.All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.

Treatment:

Drug: Hydroxychloroquine Sulfate Tablets

placebo

Other group

Description:

Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.

Treatment:

Drug: Placebo Tablets