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Recruiting NCT07334834

Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease

No phase Interventional Hyperlipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Algorithm- and multi-professional team-supported lipid management, Guideline-directed lipid management by usual care provider.
Who it may be relevant to
Registry conditions: Hyperlipidemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease: OPTIMIZE ASCVD

Overview

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

  • Other Algorithm- and multi-professional team-supported lipid management
    Algorithm- and multi-professional team-supported lipid management
  • Other Guideline-directed lipid management by usual care provider
    Guideline-directed lipid management by usual care provider

Primary outcome measures

  • The between group difference in LDL-C percent change [Time frame: Baseline to 3 months]
Secondary outcome measures (3)
  • Between group difference [Time frame: Baseline to 1 and 6 months]
  • Between group difference [Time frame: 1, 3 and 6 months]
  • Between group difference [Time frame: 1, 3 and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Health System (UCHealth) — Aurora

Identifiers

NCT: NCT07334834 · 202401CPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗