Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Phase 2

Recruiting

• Conditions: Acute Myocardial Infarction Type 1
• Interventions: Drug: Deferiprone Tablets; Drug: Placebo

• Registration Number: NCT05604131
• Lead Sponsor: Rohan Dharmakumar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-03
• Study Start: 2022-11-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2029-08-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-hemorrhagic Myocardial Infarction - Deferiprone	Deferiprone Tablets	Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage
Hemorrhagic Myocardial Infarction - Placebo	Placebo	Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage
Non-hemorrhagic Myocardial Infarction - Placebo	Placebo	Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage
Hemorrhagic Myocardial Infarction - Deferiprone	Deferiprone Tablets	Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy	6 months	Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline

Secondary Outcome Measures

Name	Time	Method
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 - 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
Treatment Effect: Clinical Outcomes of Acute Heart Failure	6 months	The proportion of subjects who experience an acute heart failure event
Safety and Tolerability - Rate of Discontinuation	6 months	Rate of discontinuation of therapy due to side effects

Trial Locations

Locations (1)

Krannert Cardiovascular Research Center; 🇺🇸 Indianapolis, Indiana, United States