Using an algorithm and team-based care to improve cholesterol in people with atherosclerotic cardiovascular disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

OPTIMIZE-ASCVD is a randomized, open-label, multicenter pilot that will randomize about 100 participants 1:1 to an algorithm- and multi-professional team-supported lipid management strategy or to usual guideline-directed care. The intervention arm uses a prescribing physician who targets an LDL-C goal without iterative titration and a pharmacist who provides medication education and helps with access issues. Usual care participants are managed by their regular providers who receive guideline summaries. The study uses decentralized elements including local CLIA-certified labs, EMR data extraction, electronic patient-reported outcomes, and remote study activities.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado Health System (UCHealth)
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Marc Bonaca, MD — Colorado Prevention Center
• Study coordinator: Marc Bonaca, MD
• Email: info@cpcmed.org
• Phone: (303) 860-9900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.