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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
The main objectives are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guideline recommended feedback | Other | 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 |
| 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 |
| Measure | Description | 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) |
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Inclusion Criteria:
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:
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:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Shaun G Goodman, MD, MSc | Co-Chair, Canadian Heart Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Heart Research Centre | Toronto | Ontario | M2J OB5 | Canada |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
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| 3-6 and 6-12 months, respectively |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |