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Heme Arginate in NSTEMI
NCT00483587Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2007
- Primary completion
- Feb 2010
- Countries
- 1
- Sponsor
- University Medical Center Groningen
- Modality
- Recombinant Proteins and Enzymes, Small Molecules
- Drugs
- heme arginate
- Conditions
- non-ST elevation myocardial infarction (NSTEMI)
01
Overview
Phase 2, open-label trial of heme arginate in non-ST elevation myocardial infarction (NSTEMI) (3 arms), sponsored by University Medical Center Groningen. Primary endpoints: Incidence rate of adverse events at 6 months and Difference in liver enzymes, clotting factors, and electrolytes at 6 months. Started Jul 2007; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
1 Dose Group
Heme arginate 3 mg/kg iv on Day 0
2 Doses Group
Heme arginate 3 mg/kg iv on Day 0 and 1
3 Doses Group
Heme arginate 3 mg/kg iv on Day 0, 1, and 2
03
Endpoints
Primary
Incidence rate of adverse events
Difference in liver enzymes, clotting factors, and electrolytes
Secondary
Activity of the HO-1 pathway
Levels of NTproBNP, CK-MB, and Troponin T
Left Ventricular Ejection Fraction
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