North American Acute Coronary Syndrome (ACS) Reflective III Pilot

Acute Coronary Syndrome Clinical Trial

Official title:

North American Acute Coronary Syndrome (ACS) Reflective III Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994575
• Other study ID #: DCV-2017-11935
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: July 2021
• Source: Canadian Heart Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: May 30, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Dyslipidemias
• 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

Locations

Country	Name	City	State
Canada	Canadian Heart Research Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Heart Research Centre	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Relative reduction of LDL-C achieved		3-6 and 6-12 months, respectively
Secondary	Proportion of patients achieving guideline-recommended targets		3-6 months
Secondary	Proportion of patients receiving additional lipid-modifying therapies (including PCSK9 inhibition)		3-6 and 6-12 months, respectively