Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada

Dyslipidemia Clinical Trial

— GOAL  

Official title:

Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537535
• Other study ID #: CHRC2014-GOAL Canada Study
• Status: Completed
• Start date: January 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Canadian Heart Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2027
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Heart Research Centre	Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean LDL-C level in patients with Familial Hypercholesterolemia		up to 2 years
Secondary	Mean LDL-C level in patients with statin intolerance		up to 2 years
Secondary	Mean LDL-C level in patients receiving combination dyslipidemia therapy		up to 2 years
Secondary	Mean LDL-C level according to statin efficacy	according to patient's statin efficacy (high, moderate, etc. by dose)	up to 2 years
Secondary	Mean LDL-C level according to their type of medication insurance coverage		up to 2 years