Neurocognitive DysfunctionNCT01186289
Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
A study testing atorvastatin in people with Neurocognitive Dysfunction, run by Duke University at 1 site in United States.
Trial summary
The primary aim of our prospective, randomized, double-blind interventional clinical trial is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neurocognitive Dysfunction
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fifty informed and consenting patients for cardiac valve surgery with CPB , greater than 50 years of age and under the care of one or more of the investigators or consultants will be prospectively enrolled over a one-year period (plus one-year for follow-up).
Who cannot join
- Patients with a history of the following disease entities will be excluded:
- symptomatic cerebrovascular disease with substantial residual deficit, alcohol abuse, psychiatric illness, renal failure (creatinine>2.0),
- hepatic dysfunction (ALT or AST > 1.5 x ULN), history of allergy or myopathy with statin therapy, pregnant or breastfeeding women or other comorbidities that in the opinion of the investigator could limit patient participation. Exclusion criteria are designed to limit confounding and enhance differentiation of deficits related to surgery and or treatment.
- Patients who are unable to read and thus unable to complete the neurocognitive testing will also be excluded.
- Patients having concomitant carotid endarterectomy or other vascular surgery will also be excluded to provide a more homogeneous sample for comparison.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The primary aim of our prospective, randomized, double-blind interventional clinical trial is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize that therapy with high dose atorvastatin will significantly reduce the incidence and/or severity of POCD.
- Conditions
- Neurocognitive Dysfunction
- Being tested
- atorvastatin
- Keywords
- Neurocognitive Dysfunction
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called Lipitor
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin | Experimental | high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively Receives: Drug: atorvastatin |
| placebo | Placebo comparator | Not described Receives: Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Dysfunction
The subject will under go a battery of neurological test at baseline, 6 weeks post surgery and at 1 year post surgery to assess neurocognitive status.
Measured: 6 weeks and 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: Principal Investigator decided not to pursue enrollment due to changes in standard of care.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Mark F Newman, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186289
- Sponsor's protocol ID
- PRO00020165
- Status last verified
- Feb 2011
- First submitted
- 19 Aug 2010
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Small BJ, Gagnon E, Robinson B. Early identification of cognitive deficits: preclinical Alzheimer's disease and mild cognitive impairment. Geriatrics. 2007 Apr;62(4):19-23.
PubMed 17408315Small N. Living well until you die: quality of care and quality of life in palliative and dementia care. Ann N Y Acad Sci. 2007 Oct;1114:194-203. doi: 10.1196/annals.1396.019. Epub 2007 Oct 12.
PubMed 17934058Newman S, Stygall J, Hirani S, Shaefi S, Maze M. Postoperative cognitive dysfunction after noncardiac surgery: a systematic review. Anesthesiology. 2007 Mar;106(3):572-90. doi: 10.1097/00000542-200703000-00023.
PubMed 17325517Newman MF, Mathew JP, Grocott HP, Mackensen GB, Monk T, Welsh-Bohmer KA, Blumenthal JA, Laskowitz DT, Mark DB. Central nervous system injury associated with cardiac surgery. Lancet. 2006 Aug 19;368(9536):694-703. doi: 10.1016/S0140-6736(06)69254-4.
PubMed 16920475Tuman KJ, McCarthy RJ, Najafi H, Ivankovich AD. Differential effects of advanced age on neurologic and cardiac risks of coronary artery operations. J Thorac Cardiovasc Surg. 1992 Dec;104(6):1510-7.
PubMed 1453714Weintraub WS, Jones EL, Craver J, Guyton R, Cohen C. Determinants of prolonged length of hospital stay after coronary bypass surgery. Circulation. 1989 Aug;80(2):276-84. doi: 10.1161/01.cir.80.2.276.
PubMed 2787709Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
PubMed 8948560Barber PA, Hach S, Tippett LJ, Ross L, Merry AF, Milsom P. Cerebral ischemic lesions on diffusion-weighted imaging are associated with neurocognitive decline after cardiac surgery. Stroke. 2008 May;39(5):1427-33. doi: 10.1161/STROKEAHA.107.502989. Epub 2008 Mar 6.
PubMed 18323490Cimino M, Gelosa P, Gianella A, Nobili E, Tremoli E, Sironi L. Statins: multiple mechanisms of action in the ischemic brain. Neuroscientist. 2007 Jun;13(3):208-13. doi: 10.1177/1073858406297121.
PubMed 17519364Rikitake Y, Liao JK. Rho GTPases, statins, and nitric oxide. Circ Res. 2005 Dec 9;97(12):1232-5. doi: 10.1161/01.RES.0000196564.18314.23.
PubMed 16339495Huang PL, Huang Z, Mashimo H, Bloch KD, Moskowitz MA, Bevan JA, Fishman MC. Hypertension in mice lacking the gene for endothelial nitric oxide synthase. Nature. 1995 Sep 21;377(6546):239-42. doi: 10.1038/377239a0.
PubMed 7545787Huang Z, Huang PL, Ma J, Meng W, Ayata C, Fishman MC, Moskowitz MA. Enlarged infarcts in endothelial nitric oxide synthase knockout mice are attenuated by nitro-L-arginine. J Cereb Blood Flow Metab. 1996 Sep;16(5):981-7. doi: 10.1097/00004647-199609000-00023.
PubMed 8784243Huang Z, Huang PL, Panahian N, Dalkara T, Fishman MC, Moskowitz MA. Effects of cerebral ischemia in mice deficient in neuronal nitric oxide synthase. Science. 1994 Sep 23;265(5180):1883-5. doi: 10.1126/science.7522345.
PubMed 7522345Dalkara T, Morikawa E, Panahian N, Moskowitz MA. Blood flow-dependent functional recovery in a rat model of focal cerebral ischemia. Am J Physiol. 1994 Aug;267(2 Pt 2):H678-83. doi: 10.1152/ajpheart.1994.267.2.H678.
PubMed 8067423Zhang F, Iadecola C. Reduction of focal cerebral ischemic damage by delayed treatment with nitric oxide donors. J Cereb Blood Flow Metab. 1994 Jul;14(4):574-80. doi: 10.1038/jcbfm.1994.71.
PubMed 8014203
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01186289
- Acronym / sponsor ID
- PRO00020165
- Conditions
- Neurocognitive Dysfunction
- Keywords
- Neurocognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator decided not to pursue enrollment due to changes in standard of care.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 23 Aug 2010 (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.
The primary aim of our prospective, randomized, double-blind interventional clinical trial is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize that therapy with high dose atorvastatin will significantly reduce the incidence and/or severity of POCD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin | Experimental | Drug: atorvastatinhigh dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively |
| placebo | Placebo comparator | Drug: atorvastatin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fifty informed and consenting patients for cardiac valve surgery with CPB , greater than 50 years of age and under the care of one or more of the investigators or consultants will be prospectively enrolled over a one-year period (plus one-year for follow-up).
Key exclusion criteria (5 listed)
- Patients with a history of the following disease entities will be excluded:
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 |
|---|---|---|
| atorvastatinAlso: Lipitorhigh dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively | Drug | atorvastatin, placebo |
Primary outcome
Neurocognitive Dysfunction
Time frame: 6 weeks and 1 year post surgery
The subject will under go a battery of neurological test at baseline, 6 weeks post surgery and at 1 year post surgery to assess neurocognitive status.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 17408315Small BJ, Gagnon E, Robinson B. Early identification of cognitive deficits: preclinical Alzheimer's disease and mild cognitive impairment. Geriatrics. 2007 Apr;62(4):19-23.
- Background: PubMed 17934058Small N. Living well until you die: quality of care and quality of life in palliative and dementia care. Ann N Y Acad Sci. 2007 Oct;1114:194-203. doi: 10.1196/annals.1396.019. Epub 2007 Oct 12.
- Background: PubMed 17325517Newman S, Stygall J, Hirani S, Shaefi S, Maze M. Postoperative cognitive dysfunction after noncardiac surgery: a systematic review. Anesthesiology. 2007 Mar;106(3):572-90. doi: 10.1097/00000542-200703000-00023.
- Background: PubMed 16920475Newman MF, Mathew JP, Grocott HP, Mackensen GB, Monk T, Welsh-Bohmer KA, Blumenthal JA, Laskowitz DT, Mark DB. Central nervous system injury associated with cardiac surgery. Lancet. 2006 Aug 19;368(9536):694-703. doi: 10.1016/S0140-6736(06)69254-4.
- Background: PubMed 1453714Tuman KJ, McCarthy RJ, Najafi H, Ivankovich AD. Differential effects of advanced age on neurologic and cardiac risks of coronary artery operations. J Thorac Cardiovasc Surg. 1992 Dec;104(6):1510-7.
- Background: PubMed 2787709Weintraub WS, Jones EL, Craver J, Guyton R, Cohen C. Determinants of prolonged length of hospital stay after coronary bypass surgery. Circulation. 1989 Aug;80(2):276-84. doi: 10.1161/01.cir.80.2.276.
- Background: PubMed 8948560Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
- Background: PubMed 18323490Barber PA, Hach S, Tippett LJ, Ross L, Merry AF, Milsom P. Cerebral ischemic lesions on diffusion-weighted imaging are associated with neurocognitive decline after cardiac surgery. Stroke. 2008 May;39(5):1427-33. doi: 10.1161/STROKEAHA.107.502989. Epub 2008 Mar 6.
- Background: PubMed 17519364Cimino M, Gelosa P, Gianella A, Nobili E, Tremoli E, Sironi L. Statins: multiple mechanisms of action in the ischemic brain. Neuroscientist. 2007 Jun;13(3):208-13. doi: 10.1177/1073858406297121.
- Background: PubMed 16339495Rikitake Y, Liao JK. Rho GTPases, statins, and nitric oxide. Circ Res. 2005 Dec 9;97(12):1232-5. doi: 10.1161/01.RES.0000196564.18314.23.
- Background: PubMed 7545787Huang PL, Huang Z, Mashimo H, Bloch KD, Moskowitz MA, Bevan JA, Fishman MC. Hypertension in mice lacking the gene for endothelial nitric oxide synthase. Nature. 1995 Sep 21;377(6546):239-42. doi: 10.1038/377239a0.
- Background: PubMed 8784243Huang Z, Huang PL, Ma J, Meng W, Ayata C, Fishman MC, Moskowitz MA. Enlarged infarcts in endothelial nitric oxide synthase knockout mice are attenuated by nitro-L-arginine. J Cereb Blood Flow Metab. 1996 Sep;16(5):981-7. doi: 10.1097/00004647-199609000-00023.
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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.
Mark F Newman, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin in people with Neurocognitive Dysfunction, run by Duke 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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. 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. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive Dysfunction (time frame: 6 weeks and 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186289, which also lists 64 linked publications.
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 14 Oct 2015.