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Completed

NCT Number: NCT02537535

Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥ 18 years old 2. High risk for cardiovascular morbidity and mortality (at least one of the following):
  • 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
  • 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
  • Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrolment
  • 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).
  • Desire and ability to execute the consent to participate.

Exclusion criteria

  • Current treatment with PCSK9 inhibitor
  • Participation in an investigational study
  • Prior participation in the GOAL program

Treatment and study plan

Survey

Other

This is a cross-sectional study without specific intervention

Primary outcomes

  1. Mean LDL-C level according to lipid lowering treatment received

    Time frame: 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 outcomes

  1. Mean LDL-C level in patients with Familial Hypercholesterolemia

    Time frame: up to 2 years

  2. Mean LDL-C level in patients with statin intolerance

    Time frame: up to 2 years

  3. Mean LDL-C level in patients receiving combination dyslipidemia therapy

    Time frame: up to 2 years

  4. Mean LDL-C level according to statin efficacy

    Time frame: up to 2 years

    according to patient's statin efficacy (high, moderate, etc. by dose)

  5. Mean LDL-C level according to their type of medication insurance coverage

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Canadian Heart Research Centre

Other

Collaborators

  • Amgen

Registry information

Acronym: GOAL

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2015
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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