NCT02392416

Brief Summary

Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias) These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation and taking into account specific parameters in the patient's profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

March 13, 2015

Last Update Submit

May 17, 2016

Conditions

HypercholesterolemiaDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • SCORE - Systematic COronary Risk Estimation

    Estimation of SCORE

    4 months

Secondary Outcomes (1)

  • Compliance (Change in 8-item Morisky Scale)

    4 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with dyslipidemia

You may qualify if:

  • External outpatients who monitored externally hospital lipid clinic, hypercholesterolemia, diabetic etc.
  • Male or female
  • Eligible ages for the study: 18-99 years
  • Patients with a first diagnosis of hypercholesterolemia who are to receive Atorvastatini according to standard clinical practice
  • Established cardiovascular disease by interventional or non-interventional examinations (such as coronary angiography, nuclear medicine, echocardiography stress, carotid plaque ultrasound), previous myocardial infarction, ACS, coronary revascularization (PCI, CABG), and other arterial revascularization procedures, ischemic stroke, peripheral arterial disease (PAD)
  • Diabetes mellitus (type 1 or type 2) with one or more cardiovascular risk factors and / or target organ damage (such as microalbuminuria: 30-300 mg / 24 h)
  • Patients already diagnosed with hypercholesterolemia and unregulated who will receive Atorvastatini according to standard clinical practice
  • Patients diagnosed and set to original formulation of atorvastatin
  • Patients who have fully understood the study protocol and signed the consent form

You may not qualify if:

  • Patients \<18 years
  • Hypersensitivity to atorvastatin or to any of the excipients
  • Women pregnant or breastfeeding
  • Patients who have not fully understood the study protocol and have not signed the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gennimatas General State Hospital

Athens, Attica, Greece

Location

2nd Cardiology Department,

University of Athens, Attikon Hospital, Haidari, Athens, 12462, Greece

Location

Related Publications (5)

  • Pitsavos C, Panagiotakos DB, Chrysohoou C, Stefanadis C. Epidemiology of cardiovascular risk factors in Greece: aims, design and baseline characteristics of the ATTICA study. BMC Public Health. 2003 Oct 20;3:32. doi: 10.1186/1471-2458-3-32.

    PMID: 14567760BACKGROUND

  • Panagiotakos DB, Pitsavos C, Manios Y, Polychronopoulos E, Chrysohoou CA, Stefanadis C. Socio-economic status in relation to risk factors associated with cardiovascular disease, in healthy individuals from the ATTICA study. Eur J Cardiovasc Prev Rehabil. 2005 Feb;12(1):68-74.

    PMID: 15703509BACKGROUND

  • Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.

    PMID: 18453793BACKGROUND

  • Krousel-Wood M, Islam T, Webber LS, Re RN, Morisky DE, Muntner P. New medication adherence scale versus pharmacy fill rates in seniors with hypertension. Am J Manag Care. 2009 Jan;15(1):59-66.

    PMID: 19146365BACKGROUND

  • Morisky DE, DiMatteo MR. Improving the measurement of self-reported medication nonadherence: response to authors. J Clin Epidemiol. 2011 Mar;64(3):255-7; discussion 258-63. doi: 10.1016/j.jclinepi.2010.09.002. Epub 2010 Dec 8. No abstract available.

    PMID: 21144706RESULT

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemias

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

GR(2)