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Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00822679
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : December 20, 2016
Last Update Posted : December 20, 2016
Southern Arizona VA Health Care System
Information provided by (Responsible Party):
Sairam Parthasarathy, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Sleep Disorder Drug: Eszopiclone Other: Placebo Phase 4

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, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome
Study Start Date : October 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Eszopiclone

Arm Intervention/treatment
Experimental: 1: Eszopiclone
Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
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

Placebo Comparator: 2: Placebo
Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Other: Placebo
Subjects are given placebo for 3 consecutive nights

Primary Outcome Measures :
  1. 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 ]
    Not performed. Zero subjects were randomized. Many potential participants screen-failed.

Secondary Outcome Measures :
  1. Changes in Objective and Subjective Measures of Sleep [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00822679

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United States, Arizona
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
Sponsors and Collaborators
University of Arizona
Southern Arizona VA Health Care System
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Principal Investigator: Sairam Parthasarathy, MD Southern Arizona VA Health Care System

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Responsible Party: Sairam Parthasarathy, Professor, University of Arizona Identifier: NCT00822679    
Other Study ID Numbers: HSC# 07-0797-01
First Posted: January 14, 2009    Key Record Dates
Results First Posted: December 20, 2016
Last Update Posted: December 20, 2016
Last Verified: October 2016
Keywords provided by Sairam Parthasarathy, University of Arizona:
Acute Coronary Syndrome
pro-coagulant mediators
sleep disorders
Additional relevant MeSH terms:
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Sleep Wake Disorders
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs