Cardiovascular RiskC2 -CORVUSNCT00921752

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

An observational study of Cardiovascular Risk, run by AstraZeneca at 26 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiovascular Risk
How many people: 1,500 participants
Where: 26 sitesHungary
Study dates: May 2009to Nov 2009
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Ambulatory clinics

Who may be able to join

Patients at high cardiovascular risk according to Framingham or SCORE rates

Who cannot join

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

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Hungary26 sites

Research Site
Baja
Research Site
Békéscsaba
Research Site
Budapest
Research Site
Budapest III District
Research Site
Cegléd
Research Site
Debrecen
Research Site
Gyöngyös
Research Site
Gyula
Research Site
Jászberény
Research Site
Kalocsa
Research Site
Karcag
Research Site
Kecskemét
Research Site
Kisvárda
Research Site
Mohács
Research Site
Nyíregyháza
Research Site
Orosháza
Research Site
Pásztó
Research Site
Püspökladány
Research Site
Salgótarján
Research Site
Szarvas
Research Site
Szécsény
Research Site
Székesfehérvár
Research Site
Szekszárd
Research Site
Szolnok
Research Site
Tatabánya
Research Site
Vác

Other trials in Hungary

About this study

Conditions: Cardiovascular Risk
Keywords: Lipid therapy, high CV risk, lipid goal attainment, High cardiovascular risk patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00921752
Study group	Role	What they receive
Patients at high cardiovascular risk		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent rate of patients achieving target LDL cholesterol goals
Measured: On each of the 3 visits performed during the study
Percent rate of patients achieving 50% or more reduction in LDL-cholesterol
Measured: 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
Measured: On each of the 3 visits performed during the study
Percent rate of compliance among patients in the study
Measured: On each of the 3 visits performed during the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Nov 2009

First posted16 Jun 2009 (estimated)
Study startMay 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00921752
Sponsor's protocol ID: NIS-CHU-DUM-2009/1
Acronym: C2 -CORVUS
Status last verified: Dec 2009
First submitted: 12 Jun 2009
Last updated: 4 Dec 2009
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 7968073
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.
PubMed 7566020
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.
PubMed 8801446
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.
PubMed 9841303
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.
PubMed 9613910
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.
PubMed 12114036
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.
PubMed 12964575

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiovascular Risk trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)
ClinicalTrials.gov ID: NCT00921752
Acronym / sponsor ID: C2 -CORVUS / NIS-CHU-DUM-2009/1
Conditions: Cardiovascular Risk
Keywords: Lipid therapy, high CV risk, lipid goal attainment, High cardiovascular risk patients
Study type: Observational
Recruitment status: Completed
Enrolment: 1,500 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2009
Study completion: Nov 2009 (actual)
First posted: 16 Jun 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients at high cardiovascular risk	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Ambulatory clinics

Key inclusion criteria (1 listed)

Patients at high cardiovascular risk according to Framingham or SCORE rates

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percent rate of patients achieving target LDL cholesterol goals
Time frame: On each of the 3 visits performed during the study
Percent rate of patients achieving 50% or more reduction in LDL-cholesterol
Time frame: On each of the 3 visits performed during the study

2 secondary outcomes

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
Percent rate of compliance among patients in the study
Time frame: On each of the 3 visits performed during the study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
Background: PubMed 7968073Randomised 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.
Background: PubMed 7566020Shepherd 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.
Background: PubMed 8801446Sacks 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.
Background: PubMed 9841303Long-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.
Background: PubMed 9613910Downs 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.
Background: PubMed 12114036Heart 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.
Background: PubMed 12964575De 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.

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ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
RecruitingPhase 3
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Ischemic Stroke, TIA
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Laszlo, MD, PHD principal investigator

County Hospital Bekes, Gyula

Csaba Csongvai, MD study director

AstraZeneca Hungary

Eva Gulyas study chair

AstraZeneca Hungary

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Risk, run by AstraZeneca at 26 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent rate of patients achieving target LDL cholesterol goals (time frame: On each of the 3 visits performed during the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00921752, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2009.