Hyperlipidemia
Conditions
Keywords
Lipid Management, Atherosclerotic Cardiovascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Carotid Artery Disease
Brief summary
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).
Detailed description
OPTIMIZE-ASCVD is a randomized, controlled, collaborative, open-label, multicenter pilot implementation science study evaluating the hypothesis that algorithm- (Appendix A) and multi-professional team-supported lipid management reduces LDL-C compared with usual care in patients with ASCVD. Approximately 100 participants will be randomized (1:1). * Participant preference for injectable vs oral lipid therapy will be recorded at baseline. * Participants allocated to algorithm-and multi-professional team-supported lipid management will be evaluated by a physician and prescribed lipid therapy which aims to achieve LDL-C target without titration. Participants will be contacted by a pharmacist to provide education about the medication and support any access issues. * Participants allocated to usual care will be referred for management by their usual care provider who will receive a summary of guideline recommendations The study will include decentralized clinical trial features including use of local, Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for blood tests, use of data extracted from the electronic medical record (EMR), electronic collection of patient-reported outcomes (PRO) and remote conduct of study activities. As an open label study with both strategy groups receiving GDMT, no Data and Safety Monitoring Committee will be convened. Study leadership will monitor aggregate data during the trial and may modify the sample size and/or cap enrollment of subgroups to ensure consistency with design assumptions.
Interventions
OTHERAlgorithm- and multi-professional team-supported lipid management
Algorithm- and multi-professional team-supported lipid management
OTHERGuideline-directed lipid management by usual care provider
Guideline-directed lipid management by usual care provider
Sponsors
Colorado Prevention Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparative Effectiveness
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provided informed consent * Age \>18 years inclusive at screening * Documented atherosclerotic vascular disease including: * 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) * Carotid artery disease (prior endarterectomy or stenting of the extracranial carotid artery or imaging evidence of carotid atherosclerosis) * Imaging evidence of atherosclerotic vascular disease in a non-coronary vascular bed (e.g. aorta, mesenteric, renal) * LDL-C \>70mg/dL
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The between group difference in LDL-C percent change | Baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference | Baseline to 1 and 6 months | LDL-C percent change |
Countries
United States
Contacts
CONTACTMarc Bonaca, MD
CONTACTSivan Naveh, MD. RPV
PRINCIPAL_INVESTIGATORMarc Bonaca, MD
Colorado Prevention Center
Outcome results
None listed