Glucagon-like peptide-1 receptor agonist (GLP-1 RA) for ASCVD

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Duke University Hospital, Durham, NC
ASCVD+5 More
SGLT2 inhibitor - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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. To accomplish this objective, we will randomly assign 9,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1:1 allocation to SGLT2i, GLP-1RA, or the combination. Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.

Eligible Conditions

  • ASCVD
  • Type2Diabetes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Through study completion on May 1, 2028, an average of 3 years of follow up for each participant

Year 3
Total (first and recurrent) cardiovascular, kidney, and death events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Glucagon-like peptide-1 receptor agonist (GLP-1 RA)
1 of 3
Sodium-glucose cotransporter-2 inhibitor (SGLT2i)
1 of 3
Combination SGLT2i and GLP-1 RA
1 of 3
Active Control

9000 Total Participants · 3 Treatment Groups

Primary Treatment: Glucagon-like peptide-1 receptor agonist (GLP-1 RA) · No Placebo Group · Phase 4

Glucagon-like peptide-1 receptor agonist (GLP-1 RA)
Drug
ActiveComparator Group · 1 Intervention: GLP-1 receptor agonist · Intervention Types: Drug
Sodium-glucose cotransporter-2 inhibitor (SGLT2i)
Drug
ActiveComparator Group · 1 Intervention: SGLT2 inhibitor · Intervention Types: Drug
Combination SGLT2i and GLP-1 RA
Drug
ActiveComparator Group · 1 Intervention: Combination drug · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion on may 1, 2028, an average of 3 years of follow up for each participant
Closest Location: Duke University Hospital · Durham, NC
Photo of durham 1Photo of durham 2Photo of durham 3
2010First Recorded Clinical Trial
1 TrialsResearching ASCVD
76 CompletedClinical Trials

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
488 Previous Clinical Trials
29,857,785 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,453 Previous Clinical Trials
9,692,244 Total Patients Enrolled
1 Trials studying ASCVD
400 Patients Enrolled for ASCVD

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 60-80 years and have at least 1 additional high-risk feature.
You are willing to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety.
You are willing to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by your usual care provider.
You are willing to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes or to combination therapy.
You are willing to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.