Dexrazoxane to Protect Against Hemorrhagic STEMI

Rohan Dharmakumar50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Myocardial Infarction (AMI)

Interventions

DexrazoxaneDRUG

Intravenous infusion administered adjunctively to primary PCI

Normal SalineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria - 1. Adult (18 - 79 years). 2. First STEMI (EMS/ER ECG ST-elevation) with TIMI 0 and primary PCI planned. 3. Consent pathway available: Patient consent, Legally Acceptable Representative (LAR) 4. CMR likely be feasible (no known MRI-unsafe implant or absolute MRI prohibition on record). Exclusion Criteria - 1. History of PCI or CABG within 1 year 2. Known dialysis/ESRD (or documented eGFR \<30 if already in record); do not wait for new labs. 3. Current anthracycline chemotherapy or active chest radiation (per patient/chart). 4. On iron chelation now or documented iron-storage disease (hemochromatosis/thalassemia). 5. Body weight \>140 kg (309 lb) by quick measurement/triage estimate. 6. Planned urgent CABG instead of PCI 7. Known pre-existing LVEF \<40% from recent records (if clearly available chart). 8. Known pregnancy or breastfeeding (history or clearly documented) 9. Concurrent trials: investigational drug or device use within 90 days. 10. Any clinically significant condition identified that would preclude safe peri-procedural administration of Dexrazoxane or completion of core protocol procedures.

Locations (1)

Synergy Cardiovascular Research Center

Rajkot, India

Outcomes

Primary Outcomes

Change in Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) expressed as a percentage. Quantified utilizing steady-state free precession (bSSFP) CMR volumetry. This measure evaluates the absolute change in global systolic function from the acute baseline phase to the follow-up phase, comparing the Dexrazoxane infusion versus the Placebo infusion.

Time frame: From Baseline (48 to 72 hours post-PCI) to 3 Months

Intramyocardial Hemorrhage Burden (IMH %LV)

Volume of intramyocardial hemorrhage expressed as a percentage of total left ventricular myocardial mass, measured by T2\* CMR

Time frame: 48-72 hours post-primary PCI

Secondary Outcomes

Change in Myocardial Infarct Size

This measure evaluates the absolute change in infarct size from the acute baseline phase to the follow-up phase, comparing the efficacy of the Dexrazoxane infusion versus the Placebo infusion.

Time frame: From Baseline (48 to 72 hours post-PCI) to 3 Months

Incidence of Major Bleeding

Assessment of bleeding complications using BARC (Bleeding Academic Research Consortium) criteria.

Time frame: From First Dose through 30 Days

Data from ClinicalTrials.gov

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