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1035 University Drive
Duluth, MN 55812
Cardiovascular Diseases
RI-CRN-2020-009, PCORI (PI: Rothman R) 07/10/2023 – 12/31/2024
Stakeholders, Technology and Research CRN (STAR CRN) Phase 3 Expansion
The STAR Clinical Research Network (CRN) focuses on people-centered research, including studies that leverage informatics tools and key stakeholders to perform pragmatic clinical trials, comparative effectiveness studies, real-world evidence research, and health system innovation.
Role: Site Co-PI
U19AG065188, NIH/NIA (PI: Alexander K) 04/01/20-08/31/26
Pragmatic Evaluation of evENTs and Benefits of Lipid-lowering in older Adults (PREVENTABLE)
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 or atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.
Role: Consortium PI, steering committee member, and Hub lead
1R01HL155396-01A1, NIH/NHLBI (PI: Daubert M) 05/01/2022 – 07/31/2026
Coronary Artery Calcium in PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (CAC PREVENTABLE)
CAC PREVENTABLE is a substudy of the multi-center PREVENTABLE trial, in which participants are randomized 1:1 to atorvastatin 40mg or placebo. The primary objective is determine the value of a biomarker-guided precision medicine approach to inform individual benefit of statin therapy in an older primary prevention population.
Role: Consortium PI, steering committee member
R18HS027402, AHRQ (Co-PI: Benziger C; Kharbanda E) 09/30/20-07/31/25
Improving Recognition and Management of Hypertension in Youth: Comparing Approaches for Extending Effective CDS for use in a Large Rural Health System
The overall goal is to evaluate the effectiveness of Peds & TeenBP, an electronic health record-linked clinical decision support (CDS) to provide patient-specific point-of-care recommendations for identification and management of elevated blood pressure and hypertension in youth. Peds & TeenBP will be implemented in a large rural health system and will compare low- and high-intensity approaches to CDS implementation through an 18-month, 3-arm cluster randomized trial in 45 primary care clinics.
Role: Co-PI
Whiteside Institute for Clinical Research (PI: Benziger C) 01/01/2021-12/31/2023
Improved Diagnosis and Genetic Confirmation of Familial Hypercholesterolemia Across the Northland (ID-FH)
The central goal of this project is to promote awareness of familial hypercholesterolemia (FH) and enroll patients with suspected FH in a registry to track therapy, clinical outcomes, and patient-reported outcomes over time, to promote optimal disease management and improve outcomes of FH patients in a largely rural population. This project is a collaboration between two health systems to improve awareness and cascade testing through a randomized patient outreach intervention.
Role: PI
A1906, Essentia Health Foundation (PI: Benziger C) 06/01/19-05/31/23
Atrial Fibrillation Risk Assessment Calculator Study (AF-RAC)
This project proposes an automated risk calculator for assessment of thromboembolism and bleeding risk that is embedded in the electronic medical record to aid clinicians and patients in a shared-decision making discussion to assess if the stroke risk outweighs the bleeding risk and leads to increased use of oral anticoagulation prescriptions.
Role: PI
n/a, Amgen 12/01/19-05/29/24
VESALIUS CV: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab in Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.
Role: Site PI
W81XWH-17-2-0030, DOD (PI: Pepine C) 01/01/20-09/14/23
Women’s IschemiA Trial to Reduce Events In Non-ObstRuctive CAD (WARRIOR)
WARRIOR trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD.
Role: Site PI
n/a, Novartis Pharmaceuticals 04/27/2022 – 03/15/2027
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease (VICTORION-2P)
This Phase III trial will evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
Role: Site PI
n/a, Novartis Pharmaceuticals 05/01/2023 – 04/16/2029
A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT).
This study is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Role: Site PI
n/a, Amgen 03/20/2023 – 06/01/2027
A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction (EVOLVE-MI)
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI].
Role: Site PI
PLACER-2020C3-21005, PCORI (PI: Everett) 04/15/2023 – 04/30/2028
PRECIDENTD (PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes)
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among three alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD.
Role: Site PI