Cardiothoracic SurgeryPhase 4NCT02029534
Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
A Phase 4 study testing Atorvastatin 20 mg and Atorvastatin 80 mg in people with Cardiothoracic Surgery and Post-operative Atrial Fibrillation, run by Creighton University at 1 site in United States.
Trial summary
This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiothoracic Surgery, Post-operative Atrial Fibrillation
- What is being tested?
- Atorvastatin 20 mg and Atorvastatin 80 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 or older
- Undergoing elective cardiothoracic surgery
Who cannot join
- Emergency cardiothoracic surgery
- History of permanent atrial fibrillation
- Acute coronary syndrome within 7 days
- Antiarrhythmic drug use in the past 3 months
- Receiving maximal tolerated dose of statin therapy
- Receiving fibrate therapy
Show all 10Show fewer
- History of statin intolerance
- Significant liver impairment (aspartate aminotransferase/alanine aminotransferase(AST/ALT)>2x ULN)
- Serum Creatinine > 3 mg/dl
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Creighton University
Omaha, Nebraska, 68131
Aiman Smer, MBBCh
Manu Kaushik, MBBS
About this study
Official title: Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation
This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.
Read the detailed description
This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.
- Being tested
- Atorvastatin 20 mg, Atorvastatin 80 mg
- Keywords
- post-operative atrial fibrillation, POAF, A-Fib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20 mgDrug
Also called Lipitor
Atorvastatin 80 mgDrug
Also called Lipitor
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 20 mg | Active comparator | atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery Receives: Drug: Atorvastatin 20 mg |
| Atorvastatin 80 mg | Experimental | atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery Receives: Drug: Atorvastatin 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of atrial fibrillation by hospital discharge
Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings.
Measured: Hospital discharge, an expected 5-7 days
Secondary outcomes (2)
Length of hospital stay
Measured: Hospital discharge, an expected 5-7 days
Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiothoracic SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiman Smer, MBBCh, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029534
- Sponsor's protocol ID
- 13-16729
- Status last verified
- Jun 2016
- First submitted
- 16 Aug 2013
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02029534
- Acronym / sponsor ID
- 13-16729
- Keywords
- post-operative atrial fibrillation, POAF, A-Fib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 Jan 2014 (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.
This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.
Detailed description
This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 20 mg | Active comparator | Drug: Atorvastatin 20 mgatorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery |
| Atorvastatin 80 mg | Experimental | Drug: Atorvastatin 80 mgatorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19 or older
- Undergoing elective cardiothoracic surgery
Key exclusion criteria (10 listed)
- Emergency cardiothoracic surgery
- History of permanent atrial fibrillation
- Acute coronary syndrome within 7 days
- Antiarrhythmic drug use in the past 3 months
- Receiving maximal tolerated dose of statin therapy
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 |
|---|---|---|
| Atorvastatin 20 mgAlso: Lipitor | Drug | Atorvastatin 20 mg |
| Atorvastatin 80 mgAlso: Lipitor | Drug | Atorvastatin 80 mg |
Primary outcome
Occurrence of atrial fibrillation by hospital discharge
Time frame: Hospital discharge, an expected 5-7 days
Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings.
2 secondary outcomes
Length of hospital stay
Time frame: Hospital discharge, an expected 5-7 days
Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
Related trials for Cardiothoracic Surgery
RecruitingObservational study
Predictive Value of Modified Caprini Score and D-Dimer in Managing Lower Limb Venous Thrombosis in Cardiothoracic Patients
DVT - Deep Vein Thrombosis
RecruitingObservational study
Factors Affect Outcomes in Cardiovascular Surgery
Coronary Artery Disease, Valvular Diseases
RecruitingObservational study
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
AKI - Acute Kidney Injury, Cardiac Surgery
RecruitingObservational study
A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves
Post Operative Pain
Recruiting
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
Renal Impairment After Cardiac Surgery, Renal Impairment
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.
Aiman Smer, MBBCh principal investigator
Creighton University
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 Atorvastatin 20 mg and Atorvastatin 80 mg in people with Cardiothoracic Surgery and Post-operative Atrial Fibrillation, run by Creighton University at 1 site in United States.
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 2 inclusion and 10 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 16 Jun 2016. 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 United States. 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. 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 Caroline Nubel (402-280-4032, carolinenubel@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of atrial fibrillation by hospital discharge (time frame: Hospital discharge, an expected 5-7 days). 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 16 Jun 2016.