Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

NCT05604131 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 13487
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction Type 1

Keywords

Acute Myocardial Infarction; Intramyocardial Hemorrhage; Deferiprone

Outcome Measures

Primary Outcomes (1)

• Treatment Efficacy

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

  6 months

Secondary Outcomes (5)

• Treatment Effect: Clinical Outcomes of Acute Heart Failure

  6 months

• Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity

  6 months

• Safety and Tolerability - Rate of Discontinuation

  6 months

• Safety and Tolerability - Severe Side Effects

  6 months

• Safety and Tolerability - Reversibility of Side Effects without Treatment

  6 months

Other Outcomes (1)

• Treatment Effect: Fat Infiltration

  6 months

Study Arms (4)

Hemorrhagic Myocardial Infarction - Deferiprone

ACTIVE COMPARATOR

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

Drug: Deferiprone Tablets

Non-hemorrhagic Myocardial Infarction - Deferiprone

ACTIVE COMPARATOR

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

Drug: Deferiprone Tablets

Hemorrhagic Myocardial Infarction - Placebo

PLACEBO COMPARATOR

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

Drug: Placebo

Non-hemorrhagic Myocardial Infarction - Placebo

PLACEBO COMPARATOR

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

Drug: Placebo

Interventions

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.

Hemorrhagic Myocardial Infarction - Deferiprone; Non-hemorrhagic Myocardial Infarction - Deferiprone

Placebo DRUG

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

Hemorrhagic Myocardial Infarction - Placebo; Non-hemorrhagic Myocardial Infarction - Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-79 years
• Index Anterior wall STEMI
• Emergency coronary angiogram with primary PCI

You may not qualify if:

• 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
• 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 - ANC \< 1.5 k/cumm
• History of Chronic Liver Disease
• Elevated hepatic enzymes (BOTH ALT and AST) \> 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 Sponsor-Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone.
• Life expectancy of less than 1 year due to non-cardiac pathology

Sponsors & Collaborators

• Rohan Dharmakumar: lead
• Minneapolis Heart Institute: collaborator

Study Sites (1)

IU Methodist Hospital (IUHealth)

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (13)

• Kali A, Kumar A, Cokic I, Tang RL, Tsaftaris SA, Friedrich MG, Dharmakumar R. Chronic manifestation of postreperfusion intramyocardial hemorrhage as regional iron deposition: a cardiovascular magnetic resonance study with ex vivo validation. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):218-28. doi: 10.1161/CIRCIMAGING.112.000133. Epub 2013 Feb 12.

  PMID: 23403335 BACKGROUND

• Kali A, Cokic I, Tang R, Dohnalkova A, Kovarik L, Yang HJ, Kumar A, Prato FS, Wood JC, Underhill D, Marban E, Dharmakumar R. Persistent Microvascular Obstruction After Myocardial Infarction Culminates in the Confluence of Ferric Iron Oxide Crystals, Proinflammatory Burden, and Adverse Remodeling. Circ Cardiovasc Imaging. 2016 Nov;9(11):e004996. doi: 10.1161/CIRCIMAGING.115.004996.

  PMID: 27903536 BACKGROUND

• Wang G, Yang HJ, Kali A, Cokic I, Tang R, Xie G, Yang Q, Francis J, Li S, Dharmakumar R. Influence of Myocardial Hemorrhage on Staging of Reperfused Myocardial Infarctions With T2 Cardiac Magnetic Resonance Imaging: Insights Into the Dependence on Infarction Type With Ex Vivo Validation. JACC Cardiovasc Imaging. 2019 Apr;12(4):693-703. doi: 10.1016/j.jcmg.2018.01.018. Epub 2018 Apr 18.

  PMID: 29680356 BACKGROUND

• Liu T, Howarth AG, Chen Y, Nair AR, Yang HJ, Ren D, Tang R, Sykes J, Kovacs MS, Dey D, Slomka P, Wood JC, Finney R, Zeng M, Prato FS, Francis J, Berman DS, Shah PK, Kumar A, Dharmakumar R. Intramyocardial Hemorrhage and the "Wave Front" of Reperfusion Injury Compromising Myocardial Salvage. J Am Coll Cardiol. 2022 Jan 4;79(1):35-48. doi: 10.1016/j.jacc.2021.10.034.

  PMID: 34991787 BACKGROUND

• Dharmakumar R. "Rusty Hearts": Is It Time to Rethink Iron Chelation Therapies in Post-Myocardial-Infarction Setting? Circ Cardiovasc Imaging. 2016 Oct;9(10):e005541. doi: 10.1161/CIRCIMAGING.116.005541. No abstract available.

  PMID: 27894072 BACKGROUND

• Dharmakumar R. Colors of Myocardial Infarction: Can They Predict the Future? Circ Cardiovasc Imaging. 2017 Dec;10(12):e007291. doi: 10.1161/CIRCIMAGING.117.007291. No abstract available.

  PMID: 29242241 BACKGROUND

• Dharmakumar R, Nair AR, Kumar A, Francis J. Myocardial Infarction and the Fine Balance of Iron. JACC Basic Transl Sci. 2021 Jul 26;6(7):581-583. doi: 10.1016/j.jacbts.2021.06.004. eCollection 2021 Jul.

  PMID: 34368506 BACKGROUND

• Guan X, Chen Y, Yang HJ, Zhang X, Ren D, Sykes J, Butler J, Han H, Zeng M, Prato FS, Dharmakumar R. Assessment of intramyocardial hemorrhage with dark-blood T2*-weighted cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2021 Jul 15;23(1):88. doi: 10.1186/s12968-021-00787-4.

  PMID: 34261494 BACKGROUND

• Chen Y, Ren D, Guan X, Yang HJ, Liu T, Tang R, Ho H, Jin H, Zeng M, Dharmakumar R. Quantification of myocardial hemorrhage using T2* cardiovascular magnetic resonance at 1.5T with ex-vivo validation. J Cardiovasc Magn Reson. 2021 Sep 30;23(1):104. doi: 10.1186/s12968-021-00779-4.

  PMID: 34587984 BACKGROUND

• Kali A, Tang RL, Kumar A, Min JK, Dharmakumar R. Detection of acute reperfusion myocardial hemorrhage with cardiac MR imaging: T2 versus T2. Radiology. 2013 Nov;269(2):387-95. doi: 10.1148/radiology.13122397. Epub 2013 Jul 11.

  PMID: 23847253 BACKGROUND

• Cokic I, Kali A, Yang HJ, Yee R, Tang R, Tighiouart M, Wang X, Jackman WS, Chugh SS, White JA, Dharmakumar R. Iron-Sensitive Cardiac Magnetic Resonance Imaging for Prediction of Ventricular Arrhythmia Risk in Patients With Chronic Myocardial Infarction: Early Evidence. Circ Cardiovasc Imaging. 2015 Aug;8(8):10.1161/CIRCIMAGING.115.003642 e003642. doi: 10.1161/CIRCIMAGING.115.003642.

  PMID: 26259581 BACKGROUND

• Cokic I, Kali A, Wang X, Yang HJ, Tang RL, Thajudeen A, Shehata M, Amorn AM, Liu E, Stewart B, Bennett N, Harlev D, Tsaftaris SA, Jackman WM, Chugh SS, Dharmakumar R. Iron deposition following chronic myocardial infarction as a substrate for cardiac electrical anomalies: initial findings in a canine model. PLoS One. 2013 Sep 16;8(9):e73193. doi: 10.1371/journal.pone.0073193. eCollection 2013.

  PMID: 24066038 BACKGROUND

• Nair AR, Johnson EA, Yang HJ, Cokic I, Francis J, Dharmakumar R. Reperfused hemorrhagic myocardial infarction in rats. PLoS One. 2020 Dec 2;15(12):e0243207. doi: 10.1371/journal.pone.0243207. eCollection 2020.

  PMID: 33264359 BACKGROUND

Related Links

• CARDIO-THERANOSTICS is developing diagnostics and therapeutics for hemorrhagic myocardial infarction

MeSH Terms

Interventions

Deferiprone

Intervention Hierarchy (Ancestors)

Pyridones; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Keyur P Vora, MD FACP FACC

  Medical Imaging Research Institute, Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Rohan Dharmakumar, PhD

  Medical Imaging Research Institute, Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

(317) 274-0985; csaha@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director, Medical Imaging Research Institute

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: November 3, 2022
• Study Start: November 8, 2022
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)