RecruitingPhase 2NCT05604131

Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients


Sponsor

Rohan Dharmakumar

Enrollment

89 participants

Start Date

Nov 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria3

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

Exclusion Criteria14

  • 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

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Interventions

DRUGDeferiprone 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.

DRUGPlacebo

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


Locations(1)

IU Methodist Hospital (IUHealth)

Indianapolis, Indiana, United States

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NCT05604131


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