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

Coronary Artery Disease Clinical Trial

— CHANGAN  

Official title:

Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874287
• Other study ID #: XJTU1AF-CRS-2016-011
• Status: Completed
• Phase: Phase 4
• Start date: October 8, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (14)

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. — View 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. Review. — View 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. Epub 2004 Feb 13. — View 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. — View 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. — View Citation

Detert J, Klaus P, Listing J, Höhne-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. — View Citation

Gottenberg JE, Ravaud P, Puéchal 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 Sjögren syndrome: the JOQUER randomized clinical trial. JAMA. 2014 Jul 16;312(3):249-58. doi: 10.1001/jama.2014.7682. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of fasting high sensitivity C-reactive protein		change from baseline at the 16th week, 39th week, 55th week.
Secondary	change of blood pressure		change from baseline at the 12th week, 20th week.
Secondary	change of fasting blood lipid		change from baseline at the 12th week, 20th week.
Secondary	change of fasting blood glucose		change from baseline at the 12th week, 20th week.
Secondary	change of fasting insulin		change from baseline at the 12th week, 20th week.
Secondary	change of echocardiogram		change from baseline at the 12th week, 20th week.
Secondary	change of fasting Interleukin 6		change from baseline at the 12th week, 20th week.
Secondary	change of fasting tumor necrosis factor		change from baseline at the 12th week, 20th week.