Dexrazoxane to Protect Against Hemorrhagic STEMI

NCT07502521 | Completed Phase 2 DMC

• 1 other identifier: 27356
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase Ila trial evaluates whether the intravenous administration of Dexrazoxane can reduce permanent heart muscle damage in patients undergoing standard stent procedures (PCI) for a severe heart attack (STEMI).

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Hemorrhagic Myocardial Infarction; Primary Percutaneous Coronary Intervention; Cardiac Magnetic Resonance; Intramyocardial Hemorrhage; ST Elevation Myocardial Infarction; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Left Ventricular Ejection Fraction (LVEF)

  Global left ventricular systolic function expressed as a percentage, quantified by steady-state free-precession cine CMR

  48-72 hours post-primary PCI

• Intramyocardial Haemorrhage Burden (IMH %LV)

  Volume of intramyocardial haemorrhage expressed as a percentage of total left ventricular myocardial mass, quantified by multi-echo T2\*-weighted gradient-echo CMR

  48-72 hours post-primary PCI

Secondary Outcomes (2)

• Myocardial Infarct Size (Infarct %LV)

  48-72 hours post-primary PCI

• Microvascular Obstruction (MVO %LV)

  48-72 hours post-primary PCI

Other Outcomes (3)

• Right Ventricular Ejection Fraction (RVEF)

  48-72 hours post-primary PCI

• High-Sensitivity Cardiac Troponin-I (hs-cTnI)

  -1 hour pre-PCI through 48 hours post-primary PCI

• Incidence of Major Bleeding (BARC Criteria)

  First dose through 30 days

Study Arms (2)

Dexrazoxane Infusion

EXPERIMENTAL

Participants receive an intravenous infusion of Dexrazoxane in the ER, followed by doses at 4, 8, and 12 hours post-primary PCI.

Drug: Dexrazoxane

Placebo Infusion

PLACEBO COMPARATOR

Participants receive an intravenous infusion of Normal Saline (0.9% NaCl) - visually identical to the investigational product - in the emergency room prior to primary PCI, followed by doses at 4, 8, and 12 hours post-primary PCI, adjunctive to standard of care.

Drug: Normal Saline

Interventions

Dexrazoxane DRUG

Intravenous infusion administered adjunctively to primary PCI

Dexrazoxane Infusion

Normal Saline DRUG

Visually identical placebo infusion (Normal Saline 0.9% NaCl) of similar volume administered adjunctively to primary percutaneous coronary intervention (PCI). Administered at four timepoints: emergency room (pre-PCI), 4 hours, 8 hours, and 12 hours post-primary PCI, identical in appearance, volume, and schedule to the investigational product.

Placebo Infusion

Eligibility Criteria

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

You may qualify if:

• Adult (18 - 79 years).
• First STEMI (EMS/ER ECG ST-elevation) with primary PCI planned.
• Consent pathway available: Patient consent, Legally Acceptable Representative (LAR)
• CMR likely be feasible (no known MRI-unsafe implant or absolute MRI prohibition)

You may not qualify if:

• History of PCI or CABG within 1 year
• Known dialysis/ESRD
• Known pre-existing LVEF \<40% from recent records
• Known pregnancy or breastfeeding (history or clearly documented)
• Current anthracycline chemotherapy or active chest radiation (per patient/chart).
• On iron chelation now or documented iron-storage disease (hemochromatosis/thalassemia).
• Concurrent trials: investigational drug or device use within 90 days.
• Any clinically significant condition identified that would preclude safe peri-procedural administration of Dexrazoxane or completion of core protocol procedures.

Sponsors & Collaborators

• Rohan Dharmakumar: lead

Study Sites (1)

Synergy Cardiovascular Research Center

Rajkot, India

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Dexrazoxane; Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Keyur P Vora, MD MS FACC

  Indiana University

  PRINCIPAL INVESTIGATOR

• Rohan Dharmakumar, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director, Medical Imaging Research Institute

Model Details: Twenty-five participants received intravenous Dexrazoxane adjunctive to primary PCI. Subsequently, 25 matched participants were prospectively enrolled as a control cohort from the same institution matched on culprit artery and ischemic determinants. Primary CMR endpoints assessed by independent blinded core laboratory at Indiana University School of Medicine.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: March 31, 2026
• Study Start: August 30, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 16, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)