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

Cardiovascular Risk Clinical Trial

— C2 -CORVUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921752
• Other study ID #: NIS-CHU-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: June 12, 2009
• Last updated: December 3, 2009
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Risk

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Hungary, 

References & Publications (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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent rate of patients achieving target LDL cholesterol goals		On each of the 3 visits performed during the study	No
Primary	Percent rate of patients achieving 50% or more reduction in LDL-cholesterol		On each of the 3 visits performed during the study	No
Secondary	Percent rate of patients achieving target secondary (total Ch, triglycerides, HDL Ch) goals		On each of the 3 visits performed during the study	No
Secondary	Percent rate of compliance among patients in the study		On each of the 3 visits performed during the study	No