Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

This study has been completed.
Sponsor:
Collaborators:
Sunovion
Southern Arizona VA Health Care System
Information provided by (Responsible Party):
Sairam Parthasarathy, University of Arizona
ClinicalTrials.gov Identifier:
NCT00822679
First received: January 12, 2009
Last updated: October 26, 2016
Last verified: October 2016
Results First Received: October 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Acute Coronary Syndrome
Sleep Disorder
Interventions: Drug: Eszopiclone
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Potential participants screen failed. There was no subject randomized (n=0).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1: Eszopiclone

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.

2: Placebo

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


Participant Flow:   Overall Study
    1: Eszopiclone   2: Placebo
STARTED   0   0 
COMPLETED   0   0 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1: Eszopiclone

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.

2: Placebo

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 Total of all reporting groups

Baseline Measures
   1: Eszopiclone   2: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Changes in Objective and Subjective Measures of Sleep   [ Time Frame: 4 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Zero subjects were randomized. Many potential participants screen-failed. Study was closed due to difficulty with recruitment.


  More Information
  Hide 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.


Results Point of Contact:  
Name/Title: Sairam Parthasarathy
Organization: University of Arizona
phone: 5206266109
e-mail: sparthasarathy@deptofmed.arizona.edu



Responsible Party: Sairam Parthasarathy, University of Arizona
ClinicalTrials.gov Identifier: NCT00822679     History of Changes
Other Study ID Numbers: HSC# 07-0797-01
Study First Received: January 12, 2009
Results First Received: October 26, 2016
Last Updated: October 26, 2016