Status:
COMPLETED
Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Southern Arizona VA Health Care System
Conditions:
Acute Coronary Syndrome
Sleep Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to examine the effects of Eszopiclone, a sleep aid, on inflammatory mediators and coagulability in patients with a recent myocardial infarction.
Detailed Description
Abnormalities of sleep are common in hospitalized patients, but the mechanisms and consequences are not well understood. In many of these patients, sleep is very disrupted, occurs during the daytime, ...
Eligibility Criteria
Inclusion
- Patients with recent (less than or equal to 8 weeks) "uncomplicated" acute myocardial infarction, can either be ST elevation MI (STEMI) or non-ST elevation MI (non-STEMI) and subsequent to successful treatment (percutaneous revascularization or medical therapy).
Exclusion
- Obstructive sleep apnea (OSA, defined as apnea-hypopnea index \> 15 per hour) or previous diagnosis of OSA.
- Patients with life-threatening arrhythmias (such as atrial fibrillation/flutter with hypotension, ventricular tachycardia, or ventricular fibrillation, or significant heart block that requires pacing \[Type III, Type IIb\]), cardiogenic shock, severe heart failure requiring high levels of inspired oxygen (FiO2 \>40%), persistent chest pain despite medical or other interventions, and patients who are considered too unstable to participate for other medical reasons or complications (such as concomitant strokes, retroperitoneal hematoma, gastro-intestinal bleeding). Also excluded are patients with history of cardiac arrest during the same hospitalization.
- Unable to take oral medications
- Use of other sedative-hypnotics
- Hypersensitivity to Eszopiclone or any component of the formulation
- Pregnancy
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00822679
Start Date
October 1 2007
End Date
January 1 2010
Last Update
December 20 2016
Active Locations (1)
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1
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723