Recruiting
Phase 2

Deferiprone Therapy

Sponsor:

Rohan Dharmakumar

Code:

NCT05604131

Conditions

Acute Myocardial Infarction Type 1

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deferiprone Tablets

Placebo

Study Details

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

Study ID

NCT05604131

Start date

Nov 8, 2022

Status verified date

Mar, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Age 18-79 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

Study Design

Enrollment

89 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hemorrhagic Myocardial Infarction - Deferiprone

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

active comparator: Non-hemorrhagic Myocardial Infarction - Deferiprone

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

placebo comparator: Hemorrhagic Myocardial Infarction - Placebo

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

placebo comparator: Non-hemorrhagic Myocardial Infarction - Placebo

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

Interventions

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

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

Primary outcome measure

  • Treatment Efficacy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

(317) 274-0985csaha@iu.edu

Locations

IU Methodist Hospital (IUHealth)

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Rohan Dharmakumar

Last update posted

Apr 8, 2026

Last verified

Mar, 2026

Keywords

  • Acute Myocardial Infarction
  • Intramyocardial Hemorrhage
  • Deferiprone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rohan Dharmakumar on 2026-04-08.