## Protocol Section
### Identification Module
**NCT ID:** NCT00822679

**Brief Title:** Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

**Official Title:** Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

#### Organization Study ID Info
**ID:** HSC# 07-0797-01
#### Organization
**Class:** OTHER
**Full Name:** University of Arizona
### Status Module
#### Completion Date
**Date:** 2010-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-12-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-10-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-12-20

**Type:** ESTIMATED

**Results First Submit Date:** 2016-10-26

**Results First Submit QC Date:** 2016-10-26

#### Start Date
**Date:** 2007-10

**Status Verified Date:** 2016-10

#### Study First Post Date
**Date:** 2009-01-14
**Type:** ESTIMATED
**Study First Submit Date:** 2009-01-12
**Study First Submit QC Date:** 2009-01-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Sumitomo Pharma America, Inc.

**Class:** FED

**Name:** Southern Arizona VA Health Care System

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Arizona

#### Responsible Party

**Investigator Affiliation:** University of Arizona

**Investigator Full Name:** Sairam Parthasarathy

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Acute Coronary Syndrome

- Sleep Disorder

**Keywords:**

- Acute Coronary Syndrome

- cytokines

- pro-coagulant mediators

- sleep disorders

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 5

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors

**Intervention Names:**

- Drug: Eszopiclone

**Label:** 1: Eszopiclone

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors

**Intervention Names:**

- Other: Placebo

**Label:** 2: Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1: Eszopiclone

**Description:** 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.

**Name:** Eszopiclone

**Other Names:**

- Lunesta

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 2: Placebo

**Description:** Subjects are given placebo for 3 consecutive nights

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**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

#### Secondary Outcomes

**Measure:** Changes in Objective and Subjective Measures of Sleep

**Time Frame:** 4 days

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tucson

**Country:** United States

**Facility:** Southern Arizona VA Health Care System

**State:** Arizona

**Zip:** 85723

#### Overall Officials

**Official 1:**

**Affiliation:** Southern Arizona VA Health Care System

**Name:** Sairam Parthasarathy, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M22242

- Name: Parasomnias

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000020447

- Term: Parasomnias

- ID: D000054058

- Term: Acute Coronary Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M475

- Name: Eszopiclone

- Relevance: HIGH

- As Found: Invasive Bladder Cancer

- ID: M6259

- Name: Coagulants

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069582

- Term: Eszopiclone

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** 1: Eszopiclone

**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.

**ID:** EG000

**Title:** 1: Eszopiclone

**Group ID:** EG001

**Title:** 2: Placebo

**Description:** 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

**ID:** EG001

**Title:** 2: Placebo

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Units:** Participants

### Group

**ID:** BG000

**Title:** 1: Eszopiclone

**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.

### Group

**ID:** BG001

**Title:** 2: Placebo

**Description:** 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

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

**Category Title:** <=18 years

**Category Title:** Between 18 and 65 years

**Category Title:** >=65 years

**Class Title:** 

### Measure

### Measure

**Category Title:** Female

**Category Title:** Male

**Class Title:** 

### Measure

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Title:** Age, Categorical
### Measure 2
**Title:** Age, Continuous
### Measure 3
**Title:** Gender
### Measure 4
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Zero subjects were randomized. Many potential participants screen-failed. Study was closed due to difficulty with recruitment.
### Point of Contact
**Email:** sparthasarathy@deptofmed.arizona.edu
**Organization:** University of Arizona
**Phone:** 5206266109
**Title:** Sairam Parthasarathy
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Not performed. Zero subjects were randomized. Many potential participants screen-failed.
**Population Description:** Not performed. Zero subjects were randomized. Many potential participants screen-failed.
**Reporting Status:** POSTED
**Time Frame:** 2 days
**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).
**Type:** PRIMARY
##### 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.
**ID:** OG000
**Title:** 1: Eszopiclone
##### Group
**Description:** 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
**ID:** OG001
**Title:** 2: Placebo
#### Outcome Measure 2
**Reporting Status:** NOT_POSTED
**Time Frame:** 4 days
**Title:** Changes in Objective and Subjective Measures of Sleep
**Type:** SECONDARY
### Participant Flow Module
#### 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.
**ID:** FG000
**Title:** 1: Eszopiclone
#### Group
**Description:** 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
**ID:** FG001
**Title:** 2: Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Recruitment Details:** Potential participants screen failed. There was no subject randomized (n=0).
**Has Results:** True