Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874287
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Hydroxychloroquine Sulfate Tablets Drug: Placebo Tablets Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.
Actual Study Start Date : October 8, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Hydroxychloroquine
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
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.
Other Name: Plaquenil

placebo
Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Drug: Placebo Tablets
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.
Other Name: placebo




Primary Outcome Measures :
  1. change of fasting high sensitivity C-reactive protein [ Time Frame: change from baseline at the 16th week, 39th week, 55th week. ]

Secondary Outcome Measures :
  1. change of blood pressure [ Time Frame: change from baseline at the 12th week, 20th week. ]
  2. change of fasting blood lipid [ Time Frame: change from baseline at the 12th week, 20th week. ]
  3. change of fasting blood glucose [ Time Frame: change from baseline at the 12th week, 20th week. ]
  4. change of fasting insulin [ Time Frame: change from baseline at the 12th week, 20th week. ]
  5. change of echocardiogram [ Time Frame: change from baseline at the 12th week, 20th week. ]
  6. change of fasting Interleukin 6 [ Time Frame: change from baseline at the 12th week, 20th week. ]
  7. change of fasting tumor necrosis factor [ Time Frame: change from baseline at the 12th week, 20th week. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874287


Contacts
Layout table for location contacts
Contact: Yue Wu, Professor 0086-029-8532-3664 imyuewu@qq.com
Contact: Mengping Liu 18709241896 745365974@qq.com

Locations
Layout table for location information
China, Shanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shanxi, China
Contact: Yue Wu, Professor    0086-029-8532-3664    imyuewu@qq.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Layout table for investigator information
Study Director: Yue Wu, Professor First Affiliated Hospital Xi'an Jiaotong University

Publications:

Layout table for additonal information
Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02874287     History of Changes
Other Study ID Numbers: XJTU1AF-CRS-2016-011
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Coronary Artery Disease
Hydroxychloroquine
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents