Ambulatory integrated primary care management program for patients with dyslipidaemia

Completed

• Conditions: Dyslipidaemia; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN66345533
• Lead Sponsor: niversity of Montreal (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Aged greater than or equal to 18 years, either sex
2. Speak and read French or English
3. Are able to give informed consent and understand and follow study procedures
4. Agree to participate and sign the informed consent
5. According to the results of their last laboratory tests (performed in the previous three months), are candidate for initiating statin monotherapy or are currently on statin monotherapy at a non-optimal dose and are not adequately controlled according to one of the following criteria:
5.1. High risk (10-year coronary heart disease [CHD] risk greater than 20%): LDL-C greater than 2.5 mmol/l and total cholesterol (TC):high-density lipoprotein (HDL-C) ratio greater than 4
5.2. Moderate risk (10-year CHD risk between 11 - 19%): LDL-C greater than 3.5 mmol/l and TC:HDL-C ratio greater than 5
6. Agree to be followed by one of the participating family physicians and one of the pharmacists for the duration of the study (12 months)
7. IPC physician agrees to refer the patient to a participating pharmacist for dyslipidaemia-treatment follow-up
8. Physician agrees to delay the beginning or change of pharmacotherapy until the initial study visit
9. Patients are not patients of a particular pharmacy or report being patients of one of the participating pharmacies

Exclusion Criteria

1. Patients already taking lipid-lowering medication and adequately controlled according to the most recent Canadian guidelines for the treatment of dyslipidaemia
2. Patients taking more than one lipid-lowering medication
3. Patients with acute cardiovascular disease (CVD) event (e.g. myocardial infarction, stroke and revascularisation) in the previous 6 months
4. Patients with a life-threatening disease or another health condition (severe mental problems, chronic alcoholism, renal insufficiency [creatinine clearance less than 60 ml/min], hepatic insufficiency [aspartate aminotransferase {AST}, alanine aminotransferase {ALT} greater than 3 x the upper normal limit] etc.) that, according to the referring physician, make them unlikely to complete the study
5. Patient with triglyceride greater than 5 mmol/l
6. Patient with LDL-C greater than 5 mmol/l
7. Patient with contraindication to statin medication (elevated transaminase levels [AST or ALT greater than 3 x the upper normal limit], history of myalgia with creatinine kinase [CK] greater than 10 x the upper normal limit)
8. Participating in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified