NCT05604131PHASE2Recruiting
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
Rohan Dharmakumar
Start Date
11/8/2022
Completion Date
8/31/2029
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.
Eligibility Criteria
Age Range: 18 years to 79 years
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
Interventions
DRUG
Deferiprone Tablets
DRUG
Placebo
Conditions
Acute Myocardial Infarction Type 1
Locations
IU Methodist Hospital (IUHealth)
Indianapolis, Indiana 46202
United States