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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Hydroxychloroquine Sulfate Tablets
* Drug: Placebo Tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hydroxychloroquine<br>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<br>* 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.<br>* Other names: Plaquenil;|
| Other: placebo<br>Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications. | Drug: Placebo Tablets<br>* 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.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of blood pressure |  | change from baseline at the 12th week, 20th week. | 
| 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 echocardiogram |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Hydroxychloroquine