Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial (OXI)

This is an interventional treatment trial for Myocardial Infarction focused on measuring Hydroxychloroquine, anti-inflammatory, Myocardial infarction, cardiovascular diseases Read More

Inclusion Criteria:

Patients must have high-sensitivity troponin or CKMB above the upper limit of normal with at least one of the following criteria:

1. Anginal symptoms suggestive of cardiac ischemia

   1. 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).
   2. Prolonged (>20 minutes) or recurrent anginal pain at rest or with minimal effort.
   3. 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.

2. ECG criteria

   1. 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.
   2. 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).