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Phase 2 Completed N=31 Randomized Triple-blind Treatment

REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction

Acute ST Elevation Myocardial Infarction
Source: ClinicalTrials.gov NCT00378352 ↗
Enrolled (actual)
31
Serious AEs
15.8%
Results posted
May 2017
Primary outcomePrimary: Infarct Size in the Territory of the Infarct Related Artery — 15.8; 15.0 percentage of LV mass

Summary

The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.

Outcome Measures

OutcomeResultp-value
PRIMARY
Infarct Size in the Territory of the Infarct Related Artery
10.6; 10.4
SECONDARY
Infarct Size in the Territory of the Infarct Related Artery
10.6; 10.4
SECONDARY
LV Ejection Fraction
48.2; 48.9; 52.5; 52.0
SECONDARY
LV Volume Indexed to BSA
34.7; 32.6; 34.1; 32.0; 65.6; 63.4
SECONDARY
LV Mass Indexed to BSA
74.2; 69.2; 67.3; 61.8
SECONDARY
Vital Signs
129.7; 126.2; 118.7; 112.9; 114.3; 114.3
SECONDARY
Hemoglobin Levels
13.8; 13.6; 13.4; 13.1; 13.3; 13.1
SECONDARY
Reticulocyte Counts
1.4; 1.3; 1.6; 1.3; 1.8; 1.3
SECONDARY
Number of Participants With Clinical Events
1; 0; 2; 0; 6; 0

Eligibility Criteria

  • INCLUSION CRITERIA:

Age greater than 21 years

Acute ST-elevation myocardial infarction

Referral for primary or rescue angioplasty

Revascularization procedure within 8 hours from the onset of ischemic symptoms

TIMI (Thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary artery at the beginning of coronary angiography

Successful revascularization of infarct-related artery

EXCLUSION CRITERIA

Clinical indication for erythropoietin

STEMI (ST-elevation myocardial infarction) due to occlusion of a branch vessel

Any history of prior MI, PCI (Percutaneous coronary intervention), CABG (Coronary artery bypass graft), cardiomyopathy, myocarditis, or CHF (congestive heart failure)

Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin

Hematocrit greater than 42% in men or greater than 40% in women at the time of study drug administration

Uncontrolled hypertension at the time of study drug administration

Cardiogenic shock

Need for coronary surgical revascularization as determined at the time of the index coronary catheterization

History of hypercoagulable disorder, thromboembolic event, or venous thrombosis

History of stroke or TIA (transient ischemic attack)

History of seizures

Contraindication to MRI

Pregnancy or nursing mother

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00378352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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