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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Hydroxychloroquine Sulfate Tablets; Drug: Placebo Tablets

• Registration Number: NCT02874287
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-22
• Study Start: 2017-10-08
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	Hydroxychloroquine Sulfate Tablets	Subjects are treated with hydroxychloroquine sulfate tablets.All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
placebo	Placebo Tablets	Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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.
change of fasting blood glucose	change from baseline at the 12th week, 20th week.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China