Phase 4 Completed N=5 Randomized Double-blind Supportive Care

Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

Coronary Artery Disease · Sleep Disorders, Intrinsic

Source: ClinicalTrials.gov NCT00822679 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Dec 2016

Primary outcomePrimary: 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).

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
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).	—	—
SECONDARY Changes in Objective and Subjective Measures of Sleep	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00822679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.