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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate Tablets
Placebo Tablets
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Hydroxychloroquine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Hydroxychloroquine

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

change of fasting high sensitivity C-reactive protein

Secondary Outcome Measures

change of blood pressure
change of fasting blood lipid
change of fasting blood glucose
change of fasting insulin
change of echocardiogram
change of fasting Interleukin 6
change of fasting tumor necrosis factor

Full Information

First Posted
August 9, 2016
Last Updated
August 26, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT02874287
Brief Title
Efficacy Study of Hydroxychloroquine to Treat High-risk Coronary Artery Disease.
Acronym
CHANGAN
Official Title
Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Hydroxychloroquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Other
Arm Description
Subjects are treated with hydroxychloroquine sulfate tablets.All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Arm Title
placebo
Arm Type
Other
Arm Description
Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate Tablets
Other Intervention Name(s)
Plaquenil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Other Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of fasting high sensitivity C-reactive protein
Time Frame
change from baseline at the 16th week, 39th week, 55th week.
Secondary Outcome Measure Information:
Title
change of blood pressure
Time Frame
change from baseline at the 12th week, 20th week.
Title
change of fasting blood lipid
Time Frame
change from baseline at the 12th week, 20th week.
Title
change of fasting blood glucose
Time Frame
change from baseline at the 12th week, 20th week.
Title
change of fasting insulin
Time Frame
change from baseline at the 12th week, 20th week.
Title
change of echocardiogram
Time Frame
change from baseline at the 12th week, 20th week.
Title
change of fasting Interleukin 6
Time Frame
change from baseline at the 12th week, 20th week.
Title
change of fasting tumor necrosis factor
Time Frame
change from baseline at the 12th week, 20th week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Wu, Professor
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19684849
Citation
Rho YH, Oeser A, Chung CP, Milne GL, Stein CM. Drugs Used in the Treatment of Rheumatoid Arthritis: Relationship between Current Use and Cardiovascular Risk Factors. Arch Drug Inf. 2009 Jun;2(2):34-40. doi: 10.1111/j.1753-5174.2009.00019.x.
Results Reference
background
PubMed Identifier
11302876
Citation
Kim WU, Seo YI, Park SH, Lee WK, Lee SK, Paek SI, Cho CS, Song HH, Kim HY. Treatment with cyclosporin switching to hydroxychloroquine in patients with rheumatoid arthritis. Ann Rheum Dis. 2001 May;60(5):514-7. doi: 10.1136/ard.60.5.514.
Results Reference
background
PubMed Identifier
25302481
Citation
Desai RJ, Eddings W, Liao KP, Solomon DH, Kim SC. Disease-modifying antirheumatic drug use and the risk of incident hyperlipidemia in patients with early rheumatoid arthritis: a retrospective cohort study. Arthritis Care Res (Hoboken). 2015 Apr;67(4):457-66. doi: 10.1002/acr.22483.
Results Reference
background
PubMed Identifier
25125385
Citation
Achuthan S, Ahluwalia J, Shafiq N, Bhalla A, Pareek A, Chandurkar N, Malhotra S. Hydroxychloroquine's Efficacy as an Antiplatelet Agent Study in Healthy Volunteers: A Proof of Concept Study. J Cardiovasc Pharmacol Ther. 2015 Mar;20(2):174-80. doi: 10.1177/1074248414546324. Epub 2014 Aug 14.
Results Reference
background
PubMed Identifier
22676348
Citation
Mercer E, Rekedal L, Garg R, Lu B, Massarotti EM, Solomon DH. Hydroxychloroquine improves insulin sensitivity in obese non-diabetic individuals. Arthritis Res Ther. 2012 Jun 7;14(3):R135. doi: 10.1186/ar3868.
Results Reference
background
PubMed Identifier
26025323
Citation
Capel RA, Herring N, Kalla M, Yavari A, Mirams GR, Douglas G, Bub G, Channon K, Paterson DJ, Terrar DA, Burton RA. Hydroxychloroquine reduces heart rate by modulating the hyperpolarization-activated current If: Novel electrophysiological insights and therapeutic potential. Heart Rhythm. 2015 Oct;12(10):2186-94. doi: 10.1016/j.hrthm.2015.05.027. Epub 2015 May 27.
Results Reference
background
PubMed Identifier
14963695
Citation
Ben-Chetrit E, Fischel R, Hinz B, Levy M. The effects of colchicine and hydroxychloroquine on the cyclo-oxygenases COX-1 and COX-2. Rheumatol Int. 2005 Jun;25(5):332-5. doi: 10.1007/s00296-004-0442-4. Epub 2004 Feb 13.
Results Reference
background
PubMed Identifier
17622600
Citation
Wasko MC, Hubert HB, Lingala VB, Elliott JR, Luggen ME, Fries JF, Ward MM. Hydroxychloroquine and risk of diabetes in patients with rheumatoid arthritis. JAMA. 2007 Jul 11;298(2):187-93. doi: 10.1001/jama.298.2.187.
Results Reference
background
PubMed Identifier
24470436
Citation
Solomon DH, Garg R, Lu B, Todd DJ, Mercer E, Norton T, Massarotti E. Effect of hydroxychloroquine on insulin sensitivity and lipid parameters in rheumatoid arthritis patients without diabetes mellitus: a randomized, blinded crossover trial. Arthritis Care Res (Hoboken). 2014 Aug;66(8):1246-51. doi: 10.1002/acr.22285.
Results Reference
background
PubMed Identifier
25027140
Citation
Gottenberg JE, Ravaud P, Puechal X, Le Guern V, Sibilia J, Goeb V, Larroche C, Dubost JJ, Rist S, Saraux A, Devauchelle-Pensec V, Morel J, Hayem G, Hatron P, Perdriger A, Sene D, Zarnitsky C, Batouche D, Furlan V, Benessiano J, Perrodeau E, Seror R, Mariette X. Effects of hydroxychloroquine on symptomatic improvement in primary Sjogren syndrome: the JOQUER randomized clinical trial. JAMA. 2014 Jul 16;312(3):249-58. doi: 10.1001/jama.2014.7682.
Results Reference
background
PubMed Identifier
26344560
Citation
Koch MW, Zabad R, Giuliani F, Hader W Jr, Lewkonia R, Metz L, Wee Yong V. Hydroxychloroquine reduces microglial activity and attenuates experimental autoimmune encephalomyelitis. J Neurol Sci. 2015 Nov 15;358(1-2):131-7. doi: 10.1016/j.jns.2015.08.1525. Epub 2015 Aug 28.
Results Reference
background
PubMed Identifier
25343023
Citation
Hage MP, Al-Badri MR, Azar ST. A favorable effect of hydroxychloroquine on glucose and lipid metabolism beyond its anti-inflammatory role. Ther Adv Endocrinol Metab. 2014 Aug;5(4):77-85. doi: 10.1177/2042018814547204.
Results Reference
background
PubMed Identifier
25693996
Citation
Al-Bari MA. Chloroquine analogues in drug discovery: new directions of uses, mechanisms of actions and toxic manifestations from malaria to multifarious diseases. J Antimicrob Chemother. 2015;70(6):1608-21. doi: 10.1093/jac/dkv018. Epub 2015 Feb 17.
Results Reference
background
PubMed Identifier
25348033
Citation
Detert J, Klaus P, Listing J, Hohne-Zimmer V, Braun T, Wassenberg S, Rau R, Buttgereit F, Burmester GR. Hydroxychloroquine in patients with inflammatory and erosive osteoarthritis of the hands (OA TREAT): study protocol for a randomized controlled trial. Trials. 2014 Oct 27;15:412. doi: 10.1186/1745-6215-15-412.
Results Reference
background

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

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