North American Acute Coronary Syndrome (ACS) Reflective III Pilot

Completed

• Conditions: Dyslipidemias; Acute Coronary Syndrome

• Registration Number: NCT03994575
• Lead Sponsor: Canadian Heart Research Centre

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-15
• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving Canadian and American guideline-recommended LDL-cholesterol goal(s)	12 months	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).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Canadian Heart Research Centre; 🇨🇦 Toronto, Ontario, Canada