C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS) - Full Text View

Purpose

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.

Condition
Cardiovascular Risk

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percent rate of patients achieving target LDL cholesterol goals [ Time Frame: On each of the 3 visits performed during the study ] [ Designated as safety issue: No ]
Percent rate of patients achieving 50% or more reduction in LDL-cholesterol [ Time Frame: On each of the 3 visits performed during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Percent rate of compliance among patients in the study [ Time Frame: On each of the 3 visits performed during the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	May 2009
Study Completion Date:	November 2009

Groups/Cohorts
Patients at high cardiovascular risk

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Ambulatory clinics

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921752

Locations

Hungary
Research Site
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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Mark Laszlo, MD, PHD	County Hospital Bekes, Gyula
Study Director:	Csaba Csongvai, MD	AstraZeneca Hungary
Study Chair:	Eva Gulyas	AstraZeneca Hungary

More Information

Publications:

[No authors listed] 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.

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.

[No authors listed] Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998 Nov 5;339(19):1349-57.

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.

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. Summary for patients in: Curr Cardiol Rep. 2002 Nov;4(6):486-7.

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-Gomér K, Perk J, Pyörälä 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. No abstract available.

Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00921752 History of Changes
Other Study ID Numbers:	NIS-CHU-DUM-2009/1
Study First Received:	June 12, 2009
Last Updated:	December 3, 2009
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:

Lipid therapy
high CV risk
lipid goal attainment
High cardiovascular risk patients

ClinicalTrials.gov processed this record on May 23, 2013