C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00921752
Collaborator
(none)
1,500
26
6
57.7
9.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)
Study Start Date
:
May 1, 2009
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients at high cardiovascular risk
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Baja | Hungary | ||
| 2 | Research Site | Bekescsaba | Hungary | ||
| 3 | Research Site | Budapest Iii District | Hungary | ||
| 4 | Research Site | Budapest | Hungary | ||
| 5 | Research Site | Cegled | Hungary | ||
| 6 | Research Site | Debrecen | Hungary | ||
| 7 | Research Site | Gyongyos | Hungary | ||
| 8 | Research Site | Gyula | Hungary | ||
| 9 | Research Site | Jaszbereny | Hungary | ||
| 10 | Research Site | Kalocsa | Hungary | ||
| 11 | Research Site | Karcag | Hungary | ||
| 12 | Research Site | Kecskemet | Hungary | ||
| 13 | Research Site | Kisvarda | Hungary | ||
| 14 | Research Site | Mohacs | Hungary | ||
| 15 | Research Site | Nyiregyhaza | Hungary | ||
| 16 | Research Site | Oroshaza | Hungary | ||
| 17 | Research Site | Paszto | Hungary | ||
| 18 | Research Site | Puspokladany | Hungary | ||
| 19 | Research Site | Salgotarjan | Hungary | ||
| 20 | Research Site | Szarvas | Hungary | ||
| 21 | Research Site | Szecseny | Hungary | ||
| 22 | Research Site | Szekesfehervar | Hungary | ||
| 23 | Research Site | Szekszard | Hungary | ||
| 24 | Research Site | Szolnok | Hungary | ||
| 25 | Research Site | Tatabanya | Hungary | ||
| 26 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00921752
Other Study ID Numbers:
- NIS-CHU-DUM-2009/1
First Posted:
Jun 16, 2009
Last Update Posted:
Dec 4, 2009
Last Verified:
Dec 1, 2009
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