Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada (GOAL)

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Other: survey

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 Type: Observational
• Enrollment (Actual): 2027

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk

Description

Inclusion Criteria:

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

1. 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

2. 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
3. Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrolment
4. 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).
5. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean LDL-C level according to lipid lowering treatment received	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	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	according to patient's statin efficacy (high, moderate, etc. by dose)	up to 2 years
Mean LDL-C level according to their type of medication insurance coverage		up to 2 years

Collaborators and Investigators

• Sponsor: Canadian Heart Research Centre
• Collaborators: Amgen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CHRC2014-GOAL Canada Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No