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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 : July 14, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dr. Anatoly Langer, Canadian Heart Research Centre

Tracking Information
First Submitted Date June 20, 2019
First Posted Date June 21, 2019
Last Update Posted Date July 14, 2020
Actual Study Start Date March 15, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2019)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 20, 2019)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title North American Acute Coronary Syndrome (ACS) Reflective III Pilot
Official Title North American Acute Coronary Syndrome (ACS) Reflective III Pilot
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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).
Condition
  • Dyslipidemias
  • Acute Coronary Syndrome
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 20, 2019)
360
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03994575
Other Study ID Numbers DCV-2017-11935
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Anatoly Langer, Canadian Heart Research Centre
Study Sponsor Canadian Heart Research Centre
Collaborators Sanofi
Investigators
Principal Investigator: Shaun G Goodman, MD, MSc Co-Chair, Canadian Heart Research Centre
PRS Account Canadian Heart Research Centre
Verification Date July 2020