Hydroxychloroquine in the prevention of cardiovascular events in high risk patients

• Conditions: Cardiovascular disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000233-73-FI
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-23
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1 Anginal Presentation
Patients of either gender who enter the hospital with prolonged or repetitive chest pain together with clearly documented ST- T wave changes indicating either unstable angina, NSTEMI or STEMI. All patients must have anginal symptoms suggestive of cardiac ischemia with one of the clinical presentations which are given in research plan
2 ECG Criteria (given in research plan; patient must have at least one)
3 Biochemical markers of myocardial damage

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1) Hypersensitivity to HCQ
2) Porfyria
3) Rheumatoid arthritis or other rheumatic disease
4) Retinopathy of any cause, or other eye diseases that could worsen by the use of HCQ
5) Significant neuropathy of any cause
6) Cardiomyopathy (dignosed before the onset of index hospitalization .i.e heart failure due to index myocardial infarction is not exclusion criteria)
7) Muscle disease (that could worsen by the use of HCQ)
8) Psoriasis
9) Any other disease or reason why investigator deems the patient not suitable for the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of hydroxychloroquine on cardiovascular risk factors in high risk cardiovascular patients;Secondary Objective: The effect of hydroxychloroquine in the prevention of future cardiovascular events in high risk cardiovascular patients;Primary end point(s): Does the HCQ therapy diminish major coronary complication (=death, acute myocardial infarctions, recurrent UAP [requiring hospitalization], urgent PCI, -CABG) event rate during six months HCQ course in ACS patients.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) The effect of HCQ on the blood lipi levels (LDL, HDL, TG)<br>2) The effect of 6 months treatment with HCQ on levels of inflammatory parameters i.e high sensitive CRP and erythrocyte sedimentation rate, <br>3) The effect of 6 months treatment with HCQ on incidence of type II diabetes and the level of HBA1c <br>4) The effect of HCQ treatment on other inflammation related parameters such as TNF-alfa, IL-6, IL-1beta, IL-18. In addition mRNA samples from serum mononuclear cells will be collected to assess the expression of key proinflammatory cytokines and genes related to inflammasome activation which has been implicated in the pathogenesis of atherosclerosis. These include the expression of NLRP3, ASC and caspase-1. <br>5) Composite endpoint of death, acute myocardial infarctions, reUAP [requiring hospitalization], urgenPCI, -CABG and stroke within nine months.<br>;Timepoint(s) of evaluation of this end point: 6 months and 9 months