Clinical trial NCT00921752: C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)
Official title: C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk
Keywords: Lipid therapy
high CV risk
lipid goal attainment
High cardiovascular risk patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ambulatory clinics

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percent rate of patients achieving target LDL cholesterol goals
timeFrame: On each of the 3 visits performed during the study
measure: Percent rate of patients achieving 50% or more reduction in LDL-cholesterol
timeFrame: On each of the 3 visits performed during the study
Secondary outcomes:
measure: Percent rate of patients achieving target secondary (total Ch, triglycerides, HDL Ch) goals
timeFrame: On each of the 3 visits performed during the study
measure: Percent rate of compliance among patients in the study
timeFrame: On each of the 3 visits performed during the study
Other outcomes:
Locations:
city: Baja
country: Hungary
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest Iii District
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyongyos
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Jaszbereny
country: Hungary
facility: Research Site
city: Kalocsa
country: Hungary
facility: Research Site
city: Karcag
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Kisvarda
country: Hungary
facility: Research Site
city: Mohacs
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Oroshaza
country: Hungary
facility: Research Site
city: Paszto
country: Hungary
facility: Research Site
city: Puspokladany
country: Hungary
facility: Research Site
city: Salgotarjan
country: Hungary
facility: Research Site
city: Szarvas
country: Hungary
facility: Research Site
city: Szecseny
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szekszard
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Vac
country: Hungary
facility: Research Site
Study officials:
affiliation: County Hospital Bekes, Gyula
name: Mark Laszlo, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Hungary
name: Csaba Csongvai, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Hungary
name: Eva Gulyas
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.