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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537535
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Dr. Anatoly Langer, 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.

Condition or disease Intervention/treatment
Dyslipidemia 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.

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Study Type : Observational
Actual Enrollment : 2027 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Intervention Details:
  • Other: survey
    This is a cross-sectional study without specific intervention


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk
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
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Responsible Party: Dr. Anatoly Langer, Anatoly Langer, MD, M.Sc., FRCP (C), FACC -Chair, Canadian Heart Research Centre, Canadian Heart Research Centre
ClinicalTrials.gov Identifier: NCT02537535    
Other Study ID Numbers: CHRC2014-GOAL Canada Study
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases