Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial (OXI)
Myocardial Infarction, Acute Coronary Syndrome, Inflammation
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Hydroxychloroquine, anti-inflammatory, Myocardial infarction, cardiovascular diseases
Eligibility Criteria
Inclusion Criteria:
Patients must have high-sensitivity troponin or CKMB above the upper limit of normal with at least one of the following criteria:
Anginal symptoms suggestive of cardiac ischemia
- Accelerating pattern of anginal pain (episodes of angina that have at least 5 minutes duration and are more frequent, severe, longer in duration and/or precipitated by less exertion).
- Prolonged (>20 minutes) or recurrent anginal pain at rest or with minimal effort.
- Anginal pain at rest or with minimal exertion, and at least 20 minutes of duration, occurring >48 hours after an acute Q-wave myocardial infarction.
ECG criteria
- New, persistent or transient ST-segment depression >0,1 mV (0,08 seconds after the J-point) in at least 2 extremity leads or 3 precordial leads.
- New, persistent or transient ST-segment elevation in two contiguous leads ≥0.2 mV in men or ≥0.15 mV in women in leads V2-V3, and/or ≥0.1 mV in other leads.
Patients will be enrolled within 96 hours of coronary angiography
Exclusion Criteria:
- Contraindication for hydroxychloroquine (porphyria, psoriasis, retinopathy, hypersensitivity)
- Rheumatoid arthritis or other rheumatic disease
- Significant neuropathy of any cause
- Cardiomyopathy (diagnosed before the onset of index hospitalization)
- Muscle disease (that could worsen by the use of hydroxychloroquine)
- Pregnant or nursing women, and women of childbearing potential without efficient contraceptives.
- Angina precipitated by obvious provoking factors
- Prolonged ECG's corrected QT interval (>480 ms)
- Ongoing antibiotic therapy of any duration
- Uncontrolled severe cardiac arrhythmia resulting in hemodynamic instability
- Severe hepatic failure (alanine transaminase or gamma-glutamyltransferase ≥2 times above normal limits or international normalized ratio (INR) >1,5 and patient not using warfarin, and due to other than cardiac reasons).
- Renal failure, glomerular filtration rate <50 ml/min/1,73m2
- Hemoglobin <100 g/l (if not possible to correct with transfusion)
- Planned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Index myocardial infarction due to PCI or CABG restenosis.
- Inability to interpret ST-T segment changes on ECG (e.g. complete left bundle branch block or paced rhythm)
- Prior thrombolytic therapy (within 12 hours)
- Inability to give informed consent
- Fulminant vomiting or other disability to give oral medication
- Over 80 years of age
- Life expectancy less than one year
- Receiving another investigational drug within 4 weeks prior to the study. (Patients who have participated in investigational trials before the 4-week time period may be randomized as long as they have reached the primary endpoint).
- Patients with any other medical condition which, in the investigator's opinion, would interfere with optimal participation in the study or produce a significant risk to the patient
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).
Sites / Locations
- Helsinki University Central Hospital
- North Karelia Central Hospital
- Kymenlaakso Central Hospital
- Päijät-Häme Central Hospital
- South Karelia Central Hospital
- South Ostrobotnia Central Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hydroxychloroquine
Placebo
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.
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.