< Practice Enhancement Programs / Guidanc
Clinical Trial Name:  
Quality Enhancement Research Initiative (QuERI) in the Dyslipidemia Management Strategy Involving Monotherapy and in Combination Therapy with Statin in High Risk Patients who have not achieved recommended LDL targets: Guideline based Undertaking to Improve Dyslipidemia mANagement in Canada (GUIDANC)

Status: CLOSED ENROLMENT AS OF AUG 25, 2008,

FDA Clinical Trial number: observational study; not applicable

Brief description:  
Observational quality enhancement initiative – provides guideline-based management strategies and feedback to physicians caring for patients who have not yet achieved guideline-recommended LDL targets. The decision to follow the recommendations and all treatment decisions are left to the physician’s discretion; there is no formal intervention or mandated treatment in this study.   

Eligibility:
Eligible patients will include both male and female adults, with an elevated plasma LDL-C level despite on-going therapy.  Approximately 2200 patients across Canada will be enrolled from 220 Canadian sites.

Eligible patients will include both male and female adults with a diagnosis of primary hypercholesterolemia who are defined as being “high-risk” as per 2006 Canadian Cardiovascular Society Working Group on Dyslipidemia Recommendations Lipid Guidelines (10-year risk of coronary artery disease > 20% based on the Framingham model, or medical history of diabetes mellitus and/or any atherosclerosis disease) and have not reached their recommended LDL-C target levels.

Inclusion Criteria
An Individual meeting the following criteria may be enrolled:

a. Patient is male or female ³ 18 years of age;

b. Patients with a diagnosis of primary hypercholesterolemia and who are defined as being “high risk” (10-year risk of coronary artery disease >20 % based on the Framingham model or a history of cardiovascular disease);

c. Patients who have not reached their recommended LDL-C target levels of 2.0 mmol/L while on Statin therapy;

d. According to the judgment of the treating physician patient enrolment is in the best interest of the patient; and,

e. Patient agrees to participate and signs an informed consent allowing follow-up and sharing of anonymous, patient-related data.


Exclusion Criteria
An individual is excluded from participating in the study if they meet any of the following criteria:

a. Individuals with poor mental function, drug or substance abuse, or individuals with unstable psychiatric illnesses, which, in the opinion of the investigator, may interfere with optimal participation in the study. Alcoholic substance abuse would be defined as a patient with alcohol consumption >14 drink per week. (A drink is: a can of beer, glass of wine, or single measure of spirits.)

b. Patients who have been treated with any investigational drug within 30 days prior to Visit 1. (If <30 days, contact the clinical monitor for a case-by-case evaluation.)

c. Patients with clinically significant concomitant illnesses of liver, muscle or kidney abnormalities.

Sponsor(s): Merck Frosst/Schering Pharmaceuticals