North American Acute Coronary Syndrome (ACS) Reflective III Pilot

Canadian Heart Research Centre

Status: Completed

Conditions: Acute Coronary Syndrome; Dyslipidemias

Treatments: Other: Guideline recommended feedback

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03994575

DCV-2017-11935

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.