Acute Coronary Syndrome | Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
Acute Coronary Syndrome research study
What is the primary objective of this study?
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug (zolpidem controlled release). The study hypothesis is that sleeping better can improve the heart recovery in patients with a diagnosis of acute coronary syndrome.
Who is eligible to participate?
Inclusion Criteria: - Patients from 18 to 75 years of age - Diagnosis of acute coronary syndrome - Capable of swallowing pills - Capable of filling in the questionaires Exclusion Criteria: - Class IV heart failure according to the New York heart association functional class, - Patients in a coma - Patients receiving mechanical ventilation - Patients who regularly use benzodiazepines or other medications for inducing sleep
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Coronary Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Zolpidem CR 12.5mgPatients will be given zolpidem CR 12.5mg each night for, at least, 3 consecutive nights, including the first night on the Cardiac ICU, when the undergo a full-night polysomnography
Drug:PlaceboPatients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Zolpidem CR 12.5mgPatients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
PlaceboPatients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
Start Date: July 2013
Completed Date: January 2014
Phase: Phase 4
Primary Outcome: Sleep efficiency
Secondary Outcome: Troponin T
Study sponsors, principal investigator, and references
Principal Investigator: Patrick R Burke, MD
Lead Sponsor: Associação Fundo de Incentivo à Pesquisa
Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico