NCT01920334

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

August 7, 2013

Last Update Submit

August 8, 2013

Conditions

Acute Coronary SyndromeSleep Deprivation

Keywords

coronary diseaseheart diseasesenzymessleeptroponinzolpidem

Outcome Measures

Primary Outcomes (1)

  • Sleep efficiency

    A full-night polysomnography is conducted in the first night on the ICU

    1 day - the first night

Secondary Outcomes (2)

  • Troponin T

    Within the first 3 days after an acute coronary syndrome diagnosis

  • Creatine-kinase MB

    Within the first 3 days after an acute coronary syndrome diagnosis

Other Outcomes (4)

  • Sleep quality analogue visual scale

    3 consecutive mornings

  • The Pittsburgh Sleep Quality Index

    1 day, before the intervention

  • Epworth Sleepiness Scale

    1 day, before the intervention

  • +1 more other outcomes

Study Arms (2)

Zolpidem CR 12.5mg

EXPERIMENTAL

Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital

Drug: Zolpidem CR 12.5mg

Placebo

PLACEBO COMPARATOR

Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital

Drug: Placebo

Interventions

Zolpidem CR 12.5mgDRUG

Patients 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

Also known as: Stillnox CR 12.5mg
Zolpidem CR 12.5mg
PlaceboDRUG

Patients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from 18 to 75 years of age
  • Diagnosis of acute coronary syndrome
  • Capable of swallowing pills
  • Capable of filling in the questionaires

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Paulo

São Paulo, São Paulo, 04023062, Brazil

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeSleep DeprivationCoronary DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaCardiovascular DiseasesVascular DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Patrick R Burke, MD

    Associação Fundo de Incentivo à Pesquisa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick R Burke, MD

CONTACT

55-11-964288591doctorburke@hotmail.com

Dalva R Poyares, MD PhD

CONTACT

55-11-21490155poyares@unifesp.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sleep Medicine PhD Student

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 12, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

BR(1)