Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial (OXI)
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|ClinicalTrials.gov Identifier: NCT02648464|
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Acute Coronary Syndrome Inflammation Hydroxychloroquine Antirheumatic Agents Cardiovascular Diseases||Drug: Hydroxychloroquine Drug: Placebo||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Hydroxychloroquine for the Prevention of Recurrent Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Hydroxychloroquine 300 mg tablet by mouth daily for 6 months. Patients under the weight of 60 kg: hydroxychloroquine 300 mg tablet daily for 5 days per week for 6 months.
Other Name: Oxiklorin
Placebo Comparator: Placebo
Placebo tablet by mouth daily for 6 months. Patients under the weight of 60 kg: placebo tablet daily for 5 days per week for 6 months.
- Rate of major cardiovascular adverse events [ Time Frame: Twelve months ]Myocardial infarction, mortality, hospitalization for unstable angina, and heart failure
- 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 [ Time Frame: Six months ]The effect of hydroxychloroquine on total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride levels
- Effect on high-sensitivity C-reactive protein (hs-CRP) level [ Time Frame: Six months ]
- Effect on soluble biomarkers of inflammation [ Time Frame: Six months ]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.
- Effect on aortic inflammation assessed by PET / CT scan [ Time Frame: Six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648464
|Helsinki University Central Hospital|
|Helsinki, Finland, 00290|
|North Karelia Central Hospital|
|Kymenlaakso Central Hospital|
|Päijät-Häme Central Hospital|
|South Karelia Central Hospital|
|South Ostrobotnia Central Hospital|
|Study Director:||Juha Sinisalo, Professor||Helsinki University Central Hospital|