Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

NCT00822679 | Completed Phase 4 Results

• 1 other identifier: HSC# 07-0797-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Sleep Disorder

Keywords

Acute Coronary Syndrome; cytokines; pro-coagulant mediators; sleep disorders

Outcome Measures

Primary Outcomes (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).

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

  2 days

Secondary Outcomes (1)

• Changes in Objective and Subjective Measures of Sleep

  4 days

Study Arms (2)

1: Eszopiclone

EXPERIMENTAL

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

Drug: Eszopiclone

2: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Eszopiclone DRUG

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.

Also known as: Lunesta

1: Eszopiclone

Placebo OTHER

Subjects are given placebo for 3 consecutive nights

2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Sumitomo Pharma America, Inc.: collaborator
• Southern Arizona VA Health Care System: collaborator

Study Sites (1)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Sleep Wake Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Limitations and Caveats

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

Results Point of Contact

• Title: Sairam Parthasarathy
• Organization: University of Arizona

sparthasarathy@deptofmed.arizona.edu

5206266109

Study Officials

• Sairam Parthasarathy, MD

  Southern Arizona VA Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 14, 2009
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 20, 2016
• Results First Posted: December 20, 2016

Record last verified: 2016-10

Locations

US (1)