Overview

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

Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Helsinki University Central Hospital
Collaborators:
Aarne Koskelo Foundation
Finnish Cultural Foundation
Finnish Foundation for Cardiovascular Research
Orion Corporation, Orion Pharma
Treatments:
Hydroxychloroquine
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:

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).