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Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Recruiting
18-79 years
All
Phase 1/2

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Overview

The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free unbound iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.

Eligibility

Inclusion Criteria

  1. Age 18-79 years
  2. Index STEMI, based on American Heart Association guidelines diagnostic criteria
  3. Coronary angiogram with primary PCI to occur irrespective of the duration of the symptoms.

Exclusion Criteria

  1. Prior history of MI / PCI / CABG
  2. Patients with history of 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 of ANC < 1.0 x 109 /L
  10. Elevated hepatic enzymes (ALT and/or AST) > 2 times of upper normal limit and not taking medications for chronic liver disease
  11. Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators
  12. 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 LIPOMED.
  13. Life expectancy of less than 1 year due to non-cardiac pathology

Study details
    Acute Myocardial Infarction Type 1

NCT05604131

Rohan Dharmakumar

15 April 2024

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