Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Study Overview
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Brief Summary
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The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free unbound iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.

Official Title
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Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Conditions
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Acute Myocardial Infarction Type 1

Intervention / Treatment
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* Drug: Deferiprone Tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Index Anterior wall STEMI, based on American Heart Association guidelines diagnostic criteria: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and ECG: New or presumed new ST-segment elevation at the J point in two or more contiguous leads with the cut-off points ≥0.2 mV in leads V1, V2, V3, or V4 and ≥ 0.1 mV in other leads Elevated biomarkers (Troponin) Coronary angiogram with primary PCI to occur irrespective of the duration of the symptoms. Exclusion Criteria Prior history of MI / PCI / CABG Patients with history of LVEF < 40% Use of investigational drugs or devices 30 days prior to randomization Known allergy or contra-indication to gadolinium/contrast agents eGFR < 30 ml/kg/min Any contraindication against cardiac MRI (such as metal implants) Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization Body weight > 140 kg (or 309 lbs.) Absolute neutrophil count of ANC < 1.0 x 109 /L Elevated hepatic enzymes (SGPT/ SGLT > 2 times of upper normal limit) Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study or confound the anticipated benefit of LIPOMED. Life expectancy of less than 1 year due to non-cardiac pathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hemorrhagic Myocardial Infarction - Deferiprone<br>Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage | Drug: Deferiprone Tablets<br>* 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.<br>|
| Active Comparator: Non-hemorrhagic Myocardial Infarction - Deferiprone<br>Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage | Drug: Deferiprone Tablets<br>* 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.<br>|
| Placebo Comparator: Hemorrhagic Myocardial Infarction - Placebo<br>Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage | Drug: Placebo<br>* Deferiprone placebo is the non-medicated formulation for a control arm of the study groups.<br>|
| Placebo Comparator: Non-hemorrhagic Myocardial Infarction - Placebo<br>Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage | Drug: Placebo<br>* Deferiprone placebo is the non-medicated formulation for a control arm of the study groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Efficacy | Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Effect: Fat Infiltration | Percentage difference of fat infiltration within the hemorrhagic myocardial infarction arms at 6 months between deferiprone and placebo groups | 6 months | 
| Treatment Effect: Clinical Outcomes | The proportion of subjects who experience an acute heart failure event The proportion of subjects who experience other non-fatal cardiovascular morbidity such as recurrent myocardial infarction, ventricular arrhythmia and CVA | 6 months | 
| Safety and Tolerability | Incidence and severity of AEs and changes from baseline of all study parameters, including clinical laboratory values, vital signs and ECG. Severity of AEs will be assessed according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0). All subjects will be monitored for AEs until resolution | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myocardial Infarction, Intramyocardial Hemorrhage, Deferiprone