Phase 2
Completed N=253
Study of Oral PG-116800 Following a Heart Attack
Myocardial Infarction · Heart Failure · Heart Enlargement
Source: ClinicalTrials.gov NCT00067236 ↗
Enrolled (actual)
253
Serious AEs
56.1%
Results posted
Nov 2011
Primary outcomePrimary: Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI) — 5.48; 5.09 mL/m2 — p=0.4239
Summary
The main purpose of the study is to test whether a possible new drug (called PG-116800) can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI) |
5.48; 5.09 | 0.4239 |
Eligibility Criteria
Inclusion:
- Be at least 18 years of age but not older than 80 years of age at screening;
- Be diagnosed with a heart attack based on electrocardiogram (ECG) and cardiac enzymes criteria;
- The qualifying heart attack has to be a first heart attack;
- The qualifying heart attack has to result in a left ventricular ejection fraction (a measure of the working efficiency of the heart) between 15% and 40%.
Exclusion:
- Documented previous history of heart attack;
- Any past history of heart failure;
- Hemodynamic instability (no instability of circulatory system);
- History of congenital heart disease and cardiomyopathy (weakened heart muscle) associated with connective tissue disorders;
- Recent history or current moderate-to-severe kidney or liver impairment;
- Significant blood dyscrasias (disorders of the blood cells);
- Females who are currently: pregnant; breast-feeding; or are of childbearing potential.
Data sourced from ClinicalTrials.gov (NCT00067236). 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.