Acute Coronary SyndromePhase 4NCT01920334
Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
A Phase 4 study testing Zolpidem CR 12.5mg in people with Acute Coronary Syndrome and Sleep Deprivation, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Sleep Deprivation
- What is being tested?
- Zolpidem CR 12.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from 18 to 75 years of age
- Diagnosis of acute coronary syndrome
- Capable of swallowing pills
- Capable of filling in the questionaires
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital São Paulo
São Paulo, São Paulo, 04023062
Patrick R Burke, MD, 55-11-964288591, doctorburke@hotmail.com
Aline G Bittencourt, MD, 55-11-964287637, alinebittencourt@hotmail.com
About this study
Official title: Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit
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.
Read the detailed description
The environment of an Intensive Care Unit (ICU) is notoriously inhospitable to patients who experience a period of sleep deprivation (SD). Recent research has shown that SD, even in the short-term, may be related to echo and electrocardiographic changes that may potentially be predictors of cardiac arrhythmias.
The objective is to evaluate the effects of early treatment with zolpidem controlled release (CR®) compared to a placebo on clinical and polysomnographic parameters for patients in a cardiac ICU who had recently been diagnosed with acute coronary syndrome.
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome. The patients in group A will receive placebo and patients in group B will receive zolpidem CR® 12.5 mg from the first night of hospitalization until their discharge. Patients will undergo overnight full polysomnography on the first night in the ICU and will complete a sleep diary with a visual analogue scale to evaluate sleep quality in the morning after the first 3 nights of hospitalization. The results of the routine ICU laboratory tests including the serum levels of cardiac enzymes [troponin T and creatine kinase MB (CK-MB)] will be collected preceding the first dose of the drug/placebo, and then daily thereafter.
- Conditions
- Acute Coronary Syndrome, Sleep Deprivation
- Being tested
- Zolpidem CR 12.5mg, Placebo
- Keywords
- coronary disease, heart diseases, enzymes, sleep, troponin, zolpidem
- Medical subject headings
- Acute Coronary Syndrome, Sleep Deprivation, Coronary Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem CR 12.5mgDrug
Also called Stillnox CR 12.5mg
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
A full-night polysomnography is conducted in the first night on the ICU
Measured: 1 day - the first night
Secondary outcomes (2)
Troponin T
The serum troponin T is measured previously of the intervention and daily for 3 consecutive days
Measured: Within the first 3 days after an acute coronary syndrome diagnosis
Creatine-kinase MB
The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days
Measured: Within the first 3 days after an acute coronary syndrome diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa
- Investigators
- Patrick R Burke, MD, Principal investigator, Associação Fundo de Incentivo à Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920334
- Sponsor's protocol ID
- 1442/11, Ethics Committee
- Other IDs
- CardioHE, AFIP
- Status last verified
- Aug 2013
- First submitted
- 7 Aug 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01920334
- Acronym / sponsor ID
- 1442/11, Ethics Committee
- Conditions
- Acute Coronary Syndrome, Sleep Deprivation
- Keywords
- coronary disease, heart diseases, enzymes, sleep, troponin, zolpidem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The environment of an Intensive Care Unit (ICU) is notoriously inhospitable to patients who experience a period of sleep deprivation (SD). Recent research has shown that SD, even in the short-term, may be related to echo and electrocardiographic changes that may potentially be predictors of cardiac arrhythmias.
The objective is to evaluate the effects of early treatment with zolpidem controlled release (CR®) compared to a placebo on clinical and polysomnographic parameters for patients in a cardiac ICU who had recently been diagnosed with acute coronary syndrome.
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome. The patients in group A will receive placebo and patients in group B will receive zolpidem CR® 12.5 mg from the first night of hospitalization until their discharge. Patients will undergo overnight full polysomnography on the first night in the ICU and will complete a sleep diary with a visual analogue scale to evaluate sleep quality in the morning after the first 3 nights of hospitalization. The results of the routine ICU laboratory tests including the serum levels of cardiac enzymes [troponin T and creatine kinase MB (CK-MB)] will be collected preceding the first dose of the drug/placebo, and then daily thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolpidem CR 12.5mg | Experimental | Drug: 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 |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients from 18 to 75 years of age
- Diagnosis of acute coronary syndrome
- Capable of swallowing pills
- Capable of filling in the questionaires
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolpidem CR 12.5mgAlso: Stillnox 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 | Zolpidem CR 12.5mg |
| 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 | Drug | Placebo |
Primary outcome
Sleep efficiency
Time frame: 1 day - the first night
A full-night polysomnography is conducted in the first night on the ICU
2 secondary outcomes
Troponin T
Time frame: Within the first 3 days after an acute coronary syndrome diagnosis
Creatine-kinase MB
Time frame: Within the first 3 days after an acute coronary syndrome diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick R Burke, MD principal investigator
Associação Fundo de Incentivo à Pesquisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem CR 12.5mg in people with Acute Coronary Syndrome and Sleep Deprivation, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick R Burke, MD (55-11-964288591, doctorburke@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: 1 day - the first night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.