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
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Tracking Information | |||||
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First Submitted Date ICMJE | December 18, 2015 | ||||
First Posted Date ICMJE | January 7, 2016 | ||||
Last Update Posted Date | June 9, 2020 | ||||
Actual Study Start Date ICMJE | February 1, 2016 | ||||
Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Rate of major cardiovascular adverse events [ Time Frame: Twelve months ] Myocardial infarction, mortality, hospitalization for unstable angina, and heart failure
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Original Primary Outcome Measures ICMJE |
Rate of major cardiovascular complications [ Time Frame: Six months ] Investigate whether hydroxychloroquine reduces the rate of death, myocardial infarction, unstable angina pectoris requiring hospitalization, and urgent coronary revascularization among acute coronary syndrome patients.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial | ||||
Official Title ICMJE | Hydroxychloroquine for the Prevention of Recurrent Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial | ||||
Brief Summary | 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. | ||||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Hartman O, Kovanen PT, Lehtonen J, Eklund KK, Sinisalo J. Hydroxychloroquine for the prevention of recurrent cardiovascular events in myocardial infarction patients: rationale and design of the OXI trial. Eur Heart J Cardiovasc Pharmacother. 2017 Apr 1;3(2):92-97. doi: 10.1093/ehjcvp/pvw035. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
125 | ||||
Original Estimated Enrollment ICMJE |
200 | ||||
Actual Study Completion Date ICMJE | December 31, 2019 | ||||
Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Patients must have high-sensitivity troponin or CKMB above the upper limit of normal with at least one of the following criteria:
Patients will be enrolled within 96 hours of coronary angiography Exclusion Criteria:
In addition, patients are not eligible for the PET/CT subgroup if they have received statin-therapy in the last 2 months prior to the hospitalization (i.e. statin therapy started during the index hospitalization is not an exclusion criteria). |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Finland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02648464 | ||||
Other Study ID Numbers ICMJE | 2015-000233-73 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Otto Hartman, Helsinki University Central Hospital | ||||
Study Sponsor ICMJE | Helsinki University Central Hospital | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Helsinki University Central Hospital | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |