The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
Deferiprone tablets are the active medication for the active arm of the study groups. Randomization will be done by investigational drug services pharmacist and intervention will be double-blinded to investigators and patients.
Deferiprone placebo is the non-medicated formulation for a control arm of the study groups.
IU Methodist Hospital (IUHealth)
Indianapolis, Indiana, United States
RECRUITINGTreatment Efficacy
Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline
Time frame: 6 months
Treatment Effect: Clinical Outcomes of Acute Heart Failure
The proportion of subjects who experience an acute heart failure event
Time frame: 6 months
Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity
The proportion of subjects who experience other non-fatal cardiovascular morbidity such as recurrent myocardial infarction, ventricular arrhythmia and CVA
Time frame: 6 months
Safety and Tolerability - Rate of Discontinuation
Rate of discontinuation of therapy due to side effects
Time frame: 6 months
Safety and Tolerability - Severe Side Effects
Rate of severe side effects requiring hospitalization, extension of length-of-stay.
Time frame: 6 months
Safety and Tolerability - Reversibility of Side Effects without Treatment
Percentage of Reversible of Side Effects without treatment
Time frame: 6 months
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