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

Sponsor

Rohan Dharmakumar (Other)

Overall Status

Recruiting

CT.gov ID

NCT05604131

Collaborator

Cardio-theranostics LLC (Other), Lipomed AG (Other)

Enrollment

Location

Arms

29.2

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction Type 1	Drug: Deferiprone Tablets Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Actual Study Start Date :

Nov 24, 2022

Anticipated Primary Completion Date :

Nov 23, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Treatment Efficacy [6 months]
Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline

Secondary Outcome Measures

Treatment Effect: Fat Infiltration [6 months]
Percentage difference of fat infiltration within the hemorrhagic myocardial infarction arms at 6 months between deferiprone and placebo groups
Treatment Effect: Clinical Outcomes [6 months]
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
Safety and Tolerability [6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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