North American Acute Coronary Syndrome (ACS) Reflective III Pilot

The North American ACS Reflective III Pilot is an observational, Quality Enhancement Research Initiative (QuERI), knowledge translation program designed to give feedback to physicians on their post-ACS lipid-lowering management in an effort to support their decision-making and choice of therapies and thereby better achieve evidence-based, guideline-recommended management of post-ACS patients. The ACS Reflective III Pilot follows the completed ACS Registries I, II, and III, ACS Reflective I, and the ongoing ACS Reflective II programs.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Acute Coronary Syndrome
• Intervention / Treatment: Other: Guideline recommended feedback

Detailed Description

The main objectives are:

1. To identify and describe post-ACS patients who do not achieve guideline-recommended LDL-C "target" (<1.8 mmol/L in Canada, >50% LDL-C lowering on high-intensity statin in the U.S.);
2. To identify opportunities where PCSK9 inhibitor therapy may be of potential benefit in the management of post-ACS patients to achieve guideline-recommended LDL-C goal by 1 year follow-up; and,
3. To determine reasons why physicians are not prescribing guideline-recommended LDL-C lowering therapies and/or patients are not achieving guideline-recommended LDL-C goals.

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2J OB5
      • Canadian Heart Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients age 18 years or older, 1-12 months post-ACS, with LDL-C ≥1.81 mmol/L (70 mg/dL) despite maximally tolerated statin ± ezetimibe therapy (including patients who are intolerant of ≥2 statins).

Description

Inclusion Criteria:

1. Patients ≥18 years of age;

2. ACS 1-12 months prior to enrolment defined by symptoms of myocardial ischemia with an unstable pattern, occurring at rest or with minimal exertion, within 72 hours of an unscheduled hospital admission due to presumed or proven obstructive coronary disease and at least one of the following:

   1. Elevated cardiac biomarkers (e.g., troponin) = myocardial infarction (MI); or,
   2. Resting ECG changes consistent with ischemia, plus additional evidence of obstructive coronary disease from regional wall motion or perfusion abnormality, 70% or greater epicardial coronary stenosis by angiography, or need for coronary revascularization procedure = unstable angina (UA); and,
3. LDL-C ≥1.81 mmol/L (70 mg/dL) despite maximally tolerated statin ± ezetimibe therapy (including patients who are intolerant of ≥2 statins).

Exclusion Criteria:

1. Participating in a research study where the lipid-modifying therapy is unknown, randomly assigned (i.e., choice not determined by the physician), or not approved for clinical use; or
2. Follow-up or life expectancy <1 year.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving Canadian and American guideline-recommended LDL-cholesterol goal(s)	The primary endpoint is the proportion of patients achieving Canadian and American guideline-recommended goals (i.e., LDL-C ≤1.8 mmol/L [70 mg/dL] or >50% LDL-C reduction, respectively, after the final visit (Visit 3; approximately 1 year post-ACS). (If, during the course of the study, the guideline-recommended LDL-C goal changes, both the current and new goals will be considered).	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Relative reduction of LDL-C achieved	3-6 and 6-12 months, respectively
Proportion of patients achieving guideline-recommended targets	3-6 months
Proportion of patients receiving additional lipid-modifying therapies (including PCSK9 inhibition)	3-6 and 6-12 months, respectively

Collaborators and Investigators

• Sponsor: Canadian Heart Research Centre
• Collaborators: Sanofi
• Investigators: Principal Investigator: Shaun G Goodman, MD, MSc, Co-Chair, Canadian Heart Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Disease; Lipid Metabolism Disorders; Syndrome; Dyslipidemias; Acute Coronary Syndrome
• Other Study ID Numbers: DCV-2017-11935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No