About this trial
This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and multi-professional team-supported lipid management reduces low density lipoprotein-cholesterol (LDL-C) compared with usual care in patients with atherosclerotic cardiovascular disease (ASCVD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provided informed consent
Age >18 years inclusive at screening
Coronary artery disease (prior revascularization, myocardial infarction, imaging evidence of coronary atherosclerosis)
Peripheral artery disease (prior revascularization, amputation, ankle: brachial index (ABI) ≤ 0.90, imaging evidence of extra-coronary atherosclerosis)
Disqualifiers
Any reason that, in the opinion of the investigator, the patient would be unable to adhere to the protocol for the duration of the study (e.g. terminal diagnosis, metastatic cancer) or in whom participation might result in harm.
Planned active titration of current lipid-lowering therapy
Myocardial infarction or arterial revascularization within prior 30 days
Trial design
Parallel
Treatments tested in this trial
Algorithm- and multi-professional team-supported lipid management
Other interventionAlgorithm- and multi-professional team-supported lipid management
Guideline-directed lipid management by usual care provider
Other interventionGuideline-directed lipid management by usual care provider
Treatment groups
Trial outcomes
Primary outcomes
The between group difference in LDL-C percent change
Secondary outcomes
Between group difference
LDL-C percent change
Between group difference
The proportion achieving LDL-C \<55 mg/dL
Between group difference
Proportion receiving combination lipid lowering Therapy
Sponsors and contacts
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