North American Acute Coronary Syndrome (ACS) Reflective III Pilot
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ClinicalTrials.gov Identifier: NCT03994575
Recruitment Status :
Enrolling by invitation
First Posted : June 21, 2019
Last Update Posted : June 25, 2019
Canadian Heart Research Centre
Information provided by (Responsible Party):
Dr. Anatoly Langer, Canadian Heart Research Centre
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.
Condition or disease
DyslipidemiasAcute Coronary Syndrome
Other: Guideline recommended feedback
The main objectives are:
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.);
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,
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.
The ACS Reflective III Pilot program is a quality assurance program where the decision to follow the recommendations and all treatment decisions related to patient care are left to the physician's discretion and feedback to the physician with their aggregate and individual patient data is intended as a quality assurance undertaking
Proportion of patients achieving Canadian and American guideline-recommended LDL-cholesterol goal(s) [ Time Frame: 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 :
Relative reduction of LDL-C achieved [ Time Frame: 3-6 and 6-12 months, respectively ]
Proportion of patients achieving guideline-recommended targets [ Time Frame: 3-6 months ]
Proportion of patients receiving additional lipid-modifying therapies (including PCSK9 inhibition) [ Time Frame: 3-6 and 6-12 months, respectively ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).
Patients ≥18 years of age;
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:
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,
LDL-C ≥1.81 mmol/L (70 mg/dL) despite maximally tolerated statin ± ezetimibe therapy (including patients who are intolerant of ≥2 statins).
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