Clinical trial NCT03994575: North American Acute Coronary Syndrome (ACS) Reflective III Pilot
Official title: North American Acute Coronary Syndrome (ACS) Reflective III Pilot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Acute Coronary Syndrome
Lead sponsor: Canadian Heart Research Centre
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2019-06-21
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving Canadian and American guideline-recommended LDL-cholesterol goal(s)
timeFrame: 12 months
Secondary outcomes:
measure: Relative reduction of LDL-C achieved
timeFrame: 3-6 and 6-12 months, respectively
measure: Proportion of patients achieving guideline-recommended targets
timeFrame: 3-6 months
measure: Proportion of patients receiving additional lipid-modifying therapies (including PCSK9 inhibition)
timeFrame: 3-6 and 6-12 months, respectively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian Heart Research Centre
state: Ontario
Study officials:
affiliation: Co-Chair, Canadian Heart Research Centre
name: Shaun G Goodman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: