Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

• Sponsor: University of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT00822679
• Collaborator: Sunovion (Industry), Southern Arizona VA Health Care System (U.S. Fed)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Oct 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

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 Names: 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

Outcome Measures

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). [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 [4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Arizona VA Health Care System	Tucson	Arizona	United States	85723

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sairam Parthasarathy, Professor, University of Arizona
• ClinicalTrials.gov Identifier: NCT00822679
• Other Study ID Numbers: HSC# 07-0797-01
• First Posted: Jan 14, 2009
• Last Update Posted: Dec 20, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Sairam Parthasarathy, Professor, University of Arizona: Acute Coronary Syndrome; cytokines; pro-coagulant mediators; sleep disorders
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Acute Coronary Syndrome; Syndrome; Eszopiclone

Study Results

Participant Flow

Recruitment Details	Potential participants screen failed. There was no subject randomized (n=0).

Arm/Group Title	1: Eszopiclone	2: Placebo
Arm/Group Description	Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors 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.	Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors Placebo: Subjects are given placebo for 3 consecutive nights
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	1: Eszopiclone	2: Placebo	Total
Arm/Group Description	Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors 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.	Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors Placebo: Subjects are given placebo for 3 consecutive nights	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Gender () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	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).
Description	Not performed. Zero subjects were randomized. Many potential participants screen-failed.
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

Not performed. Zero subjects were randomized. Many potential participants screen-failed.

Arm/Group Title	1: Eszopiclone	2: Placebo
Arm/Group Description	Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors 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.	Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors Placebo: Subjects are given placebo for 3 consecutive nights
Measure Participants	0	0

2. Secondary Outcome

Title	Changes in Objective and Subjective Measures of Sleep
Time Frame	4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	1: Eszopiclone		2: Placebo
Arm/Group Description	Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors 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.		Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors Placebo: Subjects are given placebo for 3 consecutive nights
All Cause Mortality
	1: Eszopiclone		2: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1: Eszopiclone		2: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	1: Eszopiclone		2: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Zero subjects were randomized. Many potential participants screen-failed. Study was closed due to difficulty with recruitment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.