Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients (MIRON-DFP)

Rohan Dharmakumar

Status and phase: Enrolling; Phase 2

Conditions: Acute Myocardial Infarction Type 1

Treatments: Drug: Placebo; Drug: Deferiprone Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05604131

13487

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age ≥ 18 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 4 patient groups, including a placebo group

Hemorrhagic Myocardial Infarction - Deferiprone

Active Comparator group

Description:

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

Treatment:

Drug: Deferiprone Tablets

Non-hemorrhagic Myocardial Infarction - Deferiprone

Active Comparator group

Description:

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

Treatment:

Drug: Deferiprone Tablets

Hemorrhagic Myocardial Infarction - Placebo

Placebo Comparator group

Description:

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

Treatment:

Drug: Placebo

Non-hemorrhagic Myocardial Infarction - Placebo

Placebo Comparator group

Description:

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

Treatment:

Drug: Placebo