Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00557778

Acronym

PRECAVER

Enrollment

600

Registered

2007-11-14

Start date

2007-11-30

Completion date

2010-09-30

Last updated

2011-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Dyslipidemia

Keywords

prevention, dyslipidemia

Brief summary

Evaluate the benefit (rate of adherence to the treatment), based on the LDL-C reduction in the group that will be exposed to the program of reinforcement of orientation aimed to the patients, compared to the control group, both in previous use of rosuvastatin.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects eligible for the treatment of dyslipidemia with statins according the current guidelines NCEP ATPIII and IV Brazilian Guidelines of Dyslipidemia and Atherosclerosis Prevention. * Patients with previous use of rosuvastatin for, at least, 15 days and, for no longer than12 months prior to the inclusion in the study.

Exclusion criteria

Pregnancy and childbearing * History of severe hypersensitivity (including myopathy) to other HMG-CoA reductase inhibitors. * Subjects with indication of use of cyclosporine and other associations of other lipid lowering drugs. * Subjects with underlying diseases that may influence lipid levels (i.e. uncontrolled hypothyroidism defined as a Thyroid stimulating hormone (TSH) \> 1.5 times upper level of normality (ULN) at Visit 1, AIDS, transplanted subjects, etc). * History of drug and alcohol abuse. * Current active liver disease or hepatic failure or elevations in ALT \>3 times the ULN. * Elevation of CPK \> 3 times the ULN. * Elevation in the seric creatinine \> 2,0 mg / dL. * History of malignancy in the last 5 years, except basal cell or squamous cell carcinoma of the skin (women with a history of Cervical dysplasia must be included, unless they have t3 clear consecutive Papanicolaou (Pap) smears , before the entry in the study). * Any other known clinical condition that, in the opinion of the investigator, may compromise the subject's safety.

Design outcomes

Primary

Measure	Time frame
Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation	—

Secondary

Measure	Time frame
Assess cardiovascular risk through Framingham's score, · · Identify personal characteristics of the study population regarding their health, compile demographic characteristics regarding education, economic and cultural status.	—

Countries

Brazil

Outcome results