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
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Sleep Disorder
Drug: Eszopiclone
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in objective and subjective measures of sleep [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822679

Contacts
Contact: Mary E Morrison-Barrios, BS 520-792-1450 ext 5481 mary.morrison-barrios@va.gov

Locations
United States, Arizona
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Sairam Parthasarathy, MD    520-792-1450 ext 1824    sairam.parthasarathy2@va.gov   
Contact: Mary E. Morrison-Barrios, BS    520-792-1450 ext 5481    mary.morrison-barrios@va.gov   
Principal Investigator: Sairam Parthasarathy, MD         
Sponsors and Collaborators
University of Arizona
Sunovion
Southern Arizona VA Health Care System
Investigators
Principal Investigator: Sairam Parthasarathy, MD Southern Arizona VA Health Care System
  More Information

No publications provided

Responsible Party: Sairam Parthasarathy, MD, Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier: NCT00822679     History of Changes
Other Study ID Numbers: HSC# 07-0797-01
Study First Received: January 12, 2009
Last Updated: January 13, 2009
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Arizona:
Acute Coronary Syndrome
cytokines
pro-coagulant mediators
sleep disorders

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Sleep Disorders
Parasomnias
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014