Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.
Overview
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- change of fasting high sensitivity C-reactive protein
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Hydroxychloroquine
Subjects are treated with hydroxychloroquine sulfate tablets.All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Intervention: Hydroxychloroquine Sulfate Tablets (Drug)
placebo
Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Intervention: Placebo Tablets (Drug)
Outcomes
Primary Outcomes
change of fasting high sensitivity C-reactive protein
Time Frame: change from baseline at the 16th week, 39th week, 55th week.
Secondary Outcomes
- 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.)