This safety pilot study evaluates the effect of hydroxychloroquine on preventing recurrent cardiovascular events among myocardial infarction patients. Half of the participants will receive hydroxychloroquine, whereas the other half will receive placebo during six months.
Anti-rheumatic medications decrease cardiovascular mortality in rheumatoid arthritis patients, based mainly on their anti-inflammatory effect. No studies have addressed their effect on preventing recurrent cardiovascular events among non-rheumatic patients. In the pilot phase 200 myocardial infarction patients will be recruited during their index visit to the study hospitals. Patients will be randomized after initial coronary angiography to receive either hydroxychloroquine 300 mg a day or placebo during six months. Patients will be followed up until 12 months at four visits. Visit one is at doctor´s office at 3 to 5 weeks from the day of recruitment. Visit two is at study nurse´s office at 5.5 to 6 months. Visit three is a phone interview by the study nurse at 8.5 to 9.5 months. Visit four at 11.5 to 12.5 months is at doctor´s office. This study evaluates the safety of hydroxychloroquine in the setting of myocardial infarction, and whether hydroxychloroquine treatment could reduce the incidence of recurrent cardiovascular events among myocardial infarction patients. Furthermore, the effect of hydroxychloroquine on cardiovascular risk factors and systemic inflammation parameters will be studied. In a subgroup of 40 patients, the effect of hydroxychloroquine on aortic inflammation will be assessed by PET/CT scan. If this safety pilot study with 200 patients proves successful (i.e. no major complications), 2500 patients will be recruited in additional centers in Finland and the Nordic Countries. Orion Pharma provides the active hydroxychloroquine tablet (Oxiklorin) but provides no other assistance or funding for the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
125
Helsinki University Central Hospital
Helsinki, Finland
North Karelia Central Hospital
Joensuu, Finland
Kymenlaakso Central Hospital
Kotka, Finland
Päijät-Häme Central Hospital
Lahti, Finland
South Karelia Central Hospital
Lappeenranta, Finland
South Ostrobotnia Central Hospital
Seinäjoki, Finland
Rate of major cardiovascular adverse events
Myocardial infarction, mortality, hospitalization for unstable angina, and heart failure
Time frame: Twelve months
Rate of the primary endpoint plus stroke and urgent coronary revascularization
Time frame: Twelve months
Effect on the incidence of type 2 diabetes and the level of Hba1c
Time frame: Six months
Effect on cholesterol levels
The effect of hydroxychloroquine on total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride levels
Time frame: Six months
Effect on high-sensitivity C-reactive protein (hs-CRP) level
Time frame: Six months
Effect on soluble biomarkers of inflammation
Frozen samples (plasma and whole blood) will be stored for future evaluation of biomarkers related to inflammation and cardiovascular disease, such as tumor necrosis factor alpha, interleukin 6 (IL-6), IL-1beta, IL-18, and messenger ribonucleic acid (mRNA) analyses.
Time frame: Six months
Effect on aortic inflammation assessed by PET / CT scan
Time frame: Six months
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