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

NCT00921752 | Completed

• 1 other identifier: NIS-CHU-DUM-2009/1
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 26

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.

Conditions

Cardiovascular Risk

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Percent rate of patients achieving target LDL cholesterol goals

  On each of the 3 visits performed during the study

• Percent rate of patients achieving 50% or more reduction in LDL-cholesterol

  On each of the 3 visits performed during the study

Secondary Outcomes (2)

• Percent rate of patients achieving target secondary (total Ch, triglycerides, HDL Ch) goals

  On each of the 3 visits performed during the study

• Percent rate of compliance among patients in the study

  On each of the 3 visits performed during the study

Study Arms (1)

Patients at high cardiovascular risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ambulatory clinics

You may qualify if:

• Patients at high cardiovascular risk according to Framingham or SCORE rates

You may not qualify if:

• Not eligible for lipid or statin therapy
• Intolerance to therapy
• Patients at low or intermediate CV risk

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (26)

Research Site

Baja, Hungary

Location

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Békéscsaba, Hungary

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Budapest, Hungary

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Budapest III District, Hungary

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Cegléd, Hungary

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Debrecen, Hungary

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Gyöngyös, Hungary

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Gyula, Hungary

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Jászberény, Hungary

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Kalocsa, Hungary

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Karcag, Hungary

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Kecskemét, Hungary

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Kisvárda, Hungary

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Mohács, Hungary

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Nyíregyháza, Hungary

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Orosháza, Hungary

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Pásztó, Hungary

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Püspökladány, Hungary

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Salgótarján, Hungary

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Szarvas, Hungary

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Szekszárd, Hungary

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Szécsény, Hungary

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Székesfehérvár, Hungary

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Szolnok, Hungary

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Tatabánya, Hungary

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Vác, Hungary

Location

Related Publications (7)

• 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.

  PMID: 7968073 BACKGROUND

• 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.

  PMID: 7566020 BACKGROUND

• 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.

  PMID: 8801446 BACKGROUND

• 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.

  PMID: 9841303 BACKGROUND

• 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.

  PMID: 9613910 BACKGROUND

• 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.

  PMID: 12114036 BACKGROUND

• 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.

  PMID: 12964575 BACKGROUND

Study Officials

• Mark Laszlo, MD, PHD

  County Hospital Bekes, Gyula

  PRINCIPAL INVESTIGATOR

• Csaba Csongvai, MD

  AstraZeneca Hungary

  STUDY DIRECTOR

• Eva Gulyas

  AstraZeneca Hungary

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 16, 2009
• Study Start: May 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 4, 2009

Record last verified: 2009-12

Locations

HU (26)