- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00921752
C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS) (C2 -CORVUS)
December 3, 2009 updated by: AstraZeneca
To demonstrate a higher percent rate of achieved target lipid goals among patients at high cardiovascular risk using more potent lipid-lowering treatment options including high-potency statins and combination therapies.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Baja, Hungary
- Research Site
-
Bekescsaba, Hungary
- Research Site
-
Budapest, Hungary
- Research Site
-
Budapest Iii District, Hungary
- Research Site
-
Cegled, Hungary
- Research Site
-
Debrecen, Hungary
- Research Site
-
Gyongyos, Hungary
- Research Site
-
Gyula, Hungary
- Research Site
-
Jaszbereny, Hungary
- Research Site
-
Kalocsa, Hungary
- Research Site
-
Karcag, Hungary
- Research Site
-
Kecskemet, Hungary
- Research Site
-
Kisvarda, Hungary
- Research Site
-
Mohacs, Hungary
- Research Site
-
Nyiregyhaza, Hungary
- Research Site
-
Oroshaza, Hungary
- Research Site
-
Paszto, Hungary
- Research Site
-
Puspokladany, Hungary
- Research Site
-
Salgotarjan, Hungary
- Research Site
-
Szarvas, Hungary
- Research Site
-
Szecseny, Hungary
- Research Site
-
Szekesfehervar, Hungary
- Research Site
-
Szekszard, Hungary
- Research Site
-
Szolnok, Hungary
- Research Site
-
Tatabanya, Hungary
- Research Site
-
Vac, Hungary
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Ambulatory clinics
Description
Inclusion Criteria:
- Patients at high cardiovascular risk according to Framingham or SCORE rates
Exclusion Criteria:
- Not eligible for lipid or statin therapy
- Intolerance to therapy
- Patients at low or intermediate CV risk
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Patients at high cardiovascular risk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent rate of patients achieving target LDL cholesterol goals
Time Frame: On each of the 3 visits performed during the study
|
On each of the 3 visits performed during the study
|
Percent rate of patients achieving 50% or more reduction in LDL-cholesterol
Time Frame: On each of the 3 visits performed during the study
|
On each of the 3 visits performed during the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent rate of patients achieving target secondary (total Ch, triglycerides, HDL Ch) goals
Time Frame: On each of the 3 visits performed during the study
|
On each of the 3 visits performed during the study
|
Percent rate of compliance among patients in the study
Time Frame: On each of the 3 visits performed during the study
|
On each of the 3 visits performed during the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Laszlo, MD, PHD, County Hospital Bekes, Gyula
- Study Director: Csaba Csongvai, MD, AstraZeneca Hungary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. doi: 10.1016/S0140-6736(02)09327-3.
- Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994 Nov 19;344(8934):1383-9.
- Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med. 1995 Nov 16;333(20):1301-7. doi: 10.1056/NEJM199511163332001.
- Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996 Oct 3;335(14):1001-9. doi: 10.1056/NEJM199610033351401.
- Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998 Nov 5;339(19):1349-57. doi: 10.1056/NEJM199811053391902.
- Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto AM Jr. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998 May 27;279(20):1615-22. doi: 10.1001/jama.279.20.1615.
- De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomer K, Perk J, Pyorala K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10. doi: 10.1016/s0195-668x(03)00347-6. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 12, 2009
First Submitted That Met QC Criteria
June 15, 2009
First Posted (Estimate)
June 16, 2009
Study Record Updates
Last Update Posted (Estimate)
December 4, 2009
Last Update Submitted That Met QC Criteria
December 3, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- NIS-CHU-DUM-2009/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Risk
-
University of Split, School of MedicineCompletedCardiovascular Risk Factor | Lifestyle Risk ReductionCroatia
-
University of Southern DenmarkRegion of Southern Denmark; Odense Patient Data Explorative Network; ENIGMA Solutions... and other collaboratorsActive, not recruitingCardiovascular Risk Factor | Risk CommunicationDenmark
-
Centre Hospitalier Universitaire DijonTerminatedHigh Cardiovascular Risk Patients | Low Cardiovascular Risk PatientsFrance
-
Universidad Católica San Antonio de MurciaCompleted
-
University of PittsburghAgency for Healthcare Research and Quality (AHRQ)CompletedCardiovascular RiskUnited States
-
Uppsala UniversityCompletedCardiovascular Risk Factor | Lifestyle Risk Reduction | Primary Care
-
Mayo ClinicEnrolling by invitationCardiovascular Risk | Cardiovascular PreventionUnited States
-
Universiti Putra MalaysiaBeacon Hospital Sdn BhdNot yet recruiting
-
Universidad Católica San Antonio de MurciaCompletedTo Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects (JC)Cardiovascular RiskSpain
-
University of DundeeUniversity of St AndrewsCompletedCardiovascular Risk