Acute Myocardial Infarction Type 1
Conditions
Keywords
Acute Myocardial Infarction, Intramyocardial Hemorrhage, Deferiprone
Brief summary
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.
Interventions
DRUGDeferiprone Tablets
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.
DRUGPlacebo
Deferiprone placebo is the non-medicated formulation for a control arm of the study groups.
Sponsors
Rohan Dharmakumar
Minneapolis Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-79 years 2. Index Anterior wall STEMI 3. Emergency coronary angiogram with primary PCI
Exclusion criteria
1. Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year 2. Patients with previous history of left ventricular ejection fraction (LVEF) \< 40% 3. Use of investigational drugs or devices 30 days prior to randomization 4. Known allergy or contra-indication to gadolinium/contrast agents 5. eGFR \< 30 ml/kg/min 6. Any contraindication against cardiac MRI (such as metal implants) 7. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization 8. Body weight \> 140 kg (or 309 lbs.) 9. Absolute neutrophil count - ANC \< 1.5 k/cumm 10. History of Chronic Liver Disease 11. Elevated hepatic enzymes (BOTH ALT and AST) \> 2 times of upper normal limit 12. Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators 13. Any clinically significant abnormality identified prior to randomization that in the judgment of the Sponsor-Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone. 14. Life expectancy of less than 1 year due to non-cardiac pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Efficacy | 6 months | Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Effect: Clinical Outcomes of Acute Heart Failure | 6 months | The proportion of subjects who experience an acute heart failure event |
| Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity | 6 months | The proportion of subjects who experience other non-fatal cardiovascular morbidity such as recurrent myocardial infarction, ventricular arrhythmia and CVA |
| Safety and Tolerability - Rate of Discontinuation | 6 months | Rate of discontinuation of therapy due to side effects |
| Safety and Tolerability - Severe Side Effects | 6 months | Rate of severe side effects requiring hospitalization, extension of length-of-stay. |
| Safety and Tolerability - Reversibility of Side Effects without Treatment | 6 months | Percentage of Reversible of Side Effects without treatment |
Countries
United States
Contacts
CONTACTClinical Research Coordinator
PRINCIPAL_INVESTIGATORKeyur P Vora, MD FACP FACC
Medical Imaging Research Institute, Indiana University School of Medicine
PRINCIPAL_INVESTIGATORRohan Dharmakumar, PhD
Medical Imaging Research Institute, Indiana University School of Medicine
Outcome results
None listed