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Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

Phase 4
18 Years
Open (Enrolling)
Acute Coronary Syndrome, Sleep Disorder

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Trial Information

Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

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.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

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).

Outcome Time Frame:

2 days

Safety Issue:


Principal Investigator

Sairam Parthasarathy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southern Arizona VA Health Care System


United States: Institutional Review Board

Study ID:

HSC# 07-0797-01



Start Date:

October 2007

Completion Date:

December 2009

Related Keywords:

  • Acute Coronary Syndrome
  • Sleep Disorder
  • Acute Coronary Syndrome
  • cytokines
  • pro-coagulant mediators
  • sleep disorders
  • Sleep Disorders
  • Parasomnias
  • Acute Coronary Syndrome



Southern Arizona VA Health Care SystemTucson, Arizona  85723