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Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada

Sponsor
Canadian Heart Research Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02537535
Collaborator
Amgen (Industry)
2,027
Enrollment
48
Actual Duration (Months)

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Jan 1, 2016
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Mean LDL-C level in patients with Familial Hypercholesterolemia [up to 2 years]

  2. Mean LDL-C level in patients with statin intolerance [up to 2 years]

  3. Mean LDL-C level in patients receiving combination dyslipidemia therapy [up to 2 years]

  4. Mean LDL-C level according to statin efficacy [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 [up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

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

  2. 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).

  3. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Canadian Heart Research Centre
  • Amgen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 1, 2015
Last Update Posted:
Jan 23, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dyslipidemias

Study Results

No Results Posted as of Jan 23, 2020