Dexrazoxane to Protect Against Hemorrhagic STEMI
NCT07502521 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-26
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)
Interventions
- DRUG
-
Dexrazoxane
Intravenous infusion administered adjunctively to primary PCI
- DRUG
-
Normal Saline
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.
Sponsors & Collaborators
-
Rohan Dharmakumar
lead OTHER
Principal Investigators
-
Keyur P Vora, MD MS FACC · Indiana University
-
Rohan Dharmakumar, PhD · Indiana University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-30
- Primary Completion
- 2026-02-15
- Completion
- 2026-03-16
Countries
- India
Study Locations
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