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

NCT02874287 | Completed Phase 4

• 1 other identifier: XJTU1AF-CRS-2016-011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• change of fasting high sensitivity C-reactive protein

  change from baseline at the 16th week, 39th week, 55th week.

Secondary Outcomes (7)

• 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.

Study Arms (2)

Hydroxychloroquine

OTHER

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

placebo

OTHER

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

Drug: Placebo Tablets

Interventions

Hydroxychloroquine Sulfate Tablets DRUG

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.

Also known as: Plaquenil

Hydroxychloroquine

Placebo Tablets DRUG

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.

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

Related Publications (14)

• 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.

  PMID: 19684849 BACKGROUND

• 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.

  PMID: 11302876 BACKGROUND

• 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.

  PMID: 25302481 BACKGROUND

• 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.

  PMID: 25125385 BACKGROUND

• 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.

  PMID: 22676348 BACKGROUND

• 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.

  PMID: 26025323 BACKGROUND

• 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.

  PMID: 14963695 BACKGROUND

• 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.

  PMID: 17622600 BACKGROUND

• 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.

  PMID: 24470436 BACKGROUND

• 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.

  PMID: 25027140 BACKGROUND

• 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.

  PMID: 26344560 BACKGROUND

• 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.

  PMID: 25343023 BACKGROUND

• 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.

  PMID: 25693996 BACKGROUND

• 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.

  PMID: 25348033 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yue Wu, Professor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 22, 2016
• Study Start: October 8, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

CN (1)