Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

ConditionAcute Myocardial Infarction Type 1

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorRohan Dharmakumar

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

Index Anterior wall STEMI

Emergency coronary angiogram with primary PCI

Disqualifiers

Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year

Patients with previous history of left ventricular ejection fraction (LVEF) < 40%

Use of investigational drugs or devices 30 days prior to randomization

Known allergy or contra-indication to gadolinium/contrast agents

Trial design

Design model

Parallel

Treatments tested in this trial

Deferiprone Tablets
Drug
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
Drug
Deferiprone placebo is the non-medicated formulation for a control arm of the study groups.

Treatment groups

89 Participants

are divided into 4 treatment groups

Group A: Hemorrhagic Myocardial Infarction - DeferiproneActive comparator 1 intervention

Group B: Non-hemorrhagic Myocardial Infarction - DeferiproneActive comparator 1 intervention

Group C: Hemorrhagic Myocardial Infarction - PlaceboPlacebo comparator 1 intervention

Group D: Non-hemorrhagic Myocardial Infarction - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Treatment Efficacy

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

Time frame

6 months

Secondary outcomes

Treatment Effect: Clinical Outcomes of Acute Heart Failure

The proportion of subjects who experience an acute heart failure event

Time frame

6 months

Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity

The proportion of subjects who experience other non-fatal cardiovascular morbidity such as recurrent myocardial infarction, ventricular arrhythmia and CVA

Time frame

6 months

Safety and Tolerability - Rate of Discontinuation

Rate of discontinuation of therapy due to side effects

Time frame

6 months

Safety and Tolerability - Severe Side Effects

Rate of severe side effects requiring hospitalization, extension of length-of-stay.

Time frame

6 months

Other outcomes

Treatment Effect: Fat Infiltration

Percentage difference of fat infiltration within the hemorrhagic myocardial infarction arms at 6 months between deferiprone and placebo groups

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rohan Dharmakumar

Lead sponsor

Indiana University

Sponsor institution

Minneapolis Heart Institute

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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