Clinical trial NCT02537535: Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada
Official title: Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: Canadian Heart Research Centre
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2015-09-01
Enrollment: 2027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean LDL-C level according to lipid lowering treatment received
timeFrame: up to 2 years
Secondary outcomes:
measure: Mean LDL-C level in patients with Familial Hypercholesterolemia
timeFrame: up to 2 years
measure: Mean LDL-C level in patients with statin intolerance
timeFrame: up to 2 years
measure: Mean LDL-C level in patients receiving combination dyslipidemia therapy
timeFrame: up to 2 years
measure: Mean LDL-C level according to statin efficacy
timeFrame: up to 2 years
measure: Mean LDL-C level according to their type of medication insurance coverage
timeFrame: up to 2 years
Other outcomes:
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