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Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University of Arizona.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sunovion
Southern Arizona VA Health Care System
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00822679
First received: January 12, 2009
Last updated: January 13, 2009
Last verified: January 2009

January 12, 2009
January 13, 2009
October 2007
December 2009   (final data collection date for primary outcome measure)
Changes in circulating inflammatory cytokines (Interleukin [IL]-1B, IL-6, IL-10, and Tumor Necrosis Alpha [TNF-α]) and pro-coagulant mediators (soluble P-selectin and CD40 ligand). [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822679 on ClinicalTrials.gov Archive Site
Changes in objective and subjective measures of sleep [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome
Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

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.

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, and circadian rhythm is diminished or lost. Hospitalized patients experience more frequent arousals and awakenings than is normal and show decreases in rapid eye movement and slow wave sleep. The degree of sleep fragmentation is at least equivalent to that seen in patients with obstructive sleep apnea. About 20% of arousals and awakenings are related to noise, 10% are related to health care personnel and care-related activities, and the cause for the remainder is not known, although severity of underlying disease is likely an important factor.

In studies of sleep following acute myocardial infarction, marked disturbances have been found in patients, whether in the ICU and on the wards. These disturbances include long periods of wakefulness; poor sleep efficiency, and disruption of REM sleep. The fact that there is also a loss in circadian rhythm in these patients may indicate a widespread disruption of bodily homeostasis which, in turn, may be related to the infarct itself, to a more generalized physiological response to stress or to other factors. Sleep disruption can induce sympathetic activation and elevation of blood pressure, which may contribute to patient morbidity.

It has been shown that there is an increased level of some inflammatory and coagulation factors in the recovery period following an acute myocardial infarction (MI). Post MI patients have higher levels of TNF-α, IL-6 and tissue plasminogen activator as well as lower levels of antithrombin III and protein C.

The aim of this study is to determine whether the sleep-aid Eszopiclone can improve sleep, decrease inflammation, and decrease pro-coagulation factors in patients who have recently suffered myocardial infarction when compared with a control group without sleep aids. Eszopiclone is a benzodiazepine receptor agonist which improves sleep quality by reducing the time to sleep onset and reduces wakefulness during the sleep period. Unlike benzodiazepines, it does not affect the deeper stage 3 and 4 sleep. The result is that it provides a more nearly normal night sleep than other sleep aids. It is hoped that improved sleep patterns will result in more rapid normalization of inflammatory and coagulation factors and perhaps more rapid recovery.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Acute Coronary Syndrome
  • Sleep Disorder
  • Drug: Eszopiclone
    Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older.
    Other Name: Lunesta
  • Other: Placebo
    Subjects are given placebo for 3 consecutive nights
  • Experimental: 1: Eszopiclone
    Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
    Intervention: Drug: Eszopiclone
  • Placebo Comparator: 2: Placebo
    Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact: Mary E Morrison-Barrios, BS 520-792-1450 ext 5481 mary.morrison-barrios@va.gov
United States
 
NCT00822679
HSC# 07-0797-01
No
Sairam Parthasarathy, MD, Southern Arizona VA Health Care System
University of Arizona
  • Sunovion
  • Southern Arizona VA Health Care System
Principal Investigator: Sairam Parthasarathy, MD Southern Arizona VA Health Care System
University of Arizona
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP