Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT02537535
• Lead Sponsor: Canadian Heart Research Centre

Brief Summary

Cross-sectional observational study designed to identify and describe the care gap in guideline-oriented low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk.

Detailed Description

This is a cross-sectional observational study designed to provide real-life data on the current management of dyslipidemia in high cardiovascular risk patients in routine clinical practice. Canadian guidelines recommend a target for LDL-C of ≤2.0 mmol/L (or ≥50% decrease) after treatment initiation in high-risk patients. The recommended first line treatment is statin therapy. Available data clearly indicates that up to 50% of high risk patients do not achieve this important target because of statin inadequacy or intolerance leading to non-adherence.

Therefore this program aims to provide further insights into the challenges Canadian physicians face in helping their high risk patients achieve guideline-recommended LDL-C.

Study Timeline

• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-01
• Study Start: 2016-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2027

Inclusion Criteria

1. Adults ≥ 18 years old 2. High risk for cardiovascular morbidity and mortality (at least one of the following):

2. Clinical vascular disease:

   • Coronary Artery Disease (CAD): history of myocardial infarction (MI), Coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), angiographic disease
   • Cerebrovascular Disease (CeVD): history of cerebrovascular accident (CVA) or transient ischemic attack (TIA), carotid surgery
   • Abdominal Aortic Aneurism (AAA): history of surgery/intervention
   • Peripheral Arterial Disease (PAD): history of surgery/intervention

3. Familial hypercholesterolemia defined as LDL-C > 5 mmol/L and one of:

   • typical physical findings (stigmata) such as tendon xanthomata, xanthelasma, and arcus corneae
   • personal history of early cardiovascular disease
   • family history of early cardiovascular disease or of marked hyperlipidemia

4. Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrolment

5. LDL-C > 2.0 mmol/L measured within 6 months of patient enrolment date and while on (despite) maximal tolerated statin therapy (± other lipid modifying therapies).

6. Desire and ability to execute the consent to participate.

Exclusion criteria:

1. Current treatment with PCSK9 inhibitor
2. Participation in an investigational study
3. Prior participation in the GOAL program

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean LDL-C level according to lipid lowering treatment received	up to 2 years	defined as: a. Prior cardiovascular disease, b. "High risk" Diabetes (as per Canadian Diabetes Association Guidelines), c. High risk patients based on Framingham score; and according to LDL-C between 2.5 and 3.0 mmol/L and LDL \> 3.0 mmol/L

Secondary Outcome Measures

Name	Time	Method
Mean LDL-C level in patients with Familial Hypercholesterolemia	up to 2 years
Mean LDL-C level in patients with statin intolerance	up to 2 years
Mean LDL-C level in patients receiving combination dyslipidemia therapy	up to 2 years
Mean LDL-C level according to statin efficacy	up to 2 years	according to patient's statin efficacy (high, moderate, etc. by dose)
Mean LDL-C level according to their type of medication insurance coverage	up to 2 years