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North American Acute Coronary Syndrome (ACS) Reflective III Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994575
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dr. Anatoly Langer, 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.

Condition or disease Intervention/treatment
Dyslipidemias Acute Coronary Syndrome Other: Guideline recommended feedback

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: North American Acute Coronary Syndrome (ACS) Reflective III Pilot
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Intervention Details:
  • Other: Guideline recommended feedback
    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


Primary Outcome Measures :
  1. 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 :
  1. Relative reduction of LDL-C achieved [ Time Frame: 3-6 and 6-12 months, respectively ]
  2. Proportion of patients achieving guideline-recommended targets [ Time Frame: 3-6 months ]
  3. Proportion of patients receiving additional lipid-modifying therapies (including PCSK9 inhibition) [ Time Frame: 3-6 and 6-12 months, respectively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994575


Locations
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Canada, Ontario
Canadian Heart Research Centre
Toronto, Ontario, Canada, M2J OB5
Sponsors and Collaborators
Canadian Heart Research Centre
Sanofi
Investigators
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Principal Investigator: Shaun G Goodman, MD, MSc Co-Chair, Canadian Heart Research Centre
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Responsible Party: Dr. Anatoly Langer, Director, Canadian Heart Research Centre
ClinicalTrials.gov Identifier: NCT03994575    
Other Study ID Numbers: DCV-2017-11935
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Dyslipidemias
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases