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Cholesterol Absorption Inhibitor

PCSK9 inhibitor for Type 2 Diabetes (CHORD Trial)

Phase 4
Waitlist Available
Led By Jeffrey Berger, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow up visit (4 weeks)
Awards & highlights

CHORD Trial Summary

This trial is investigating the difference in heart disease risk factors for those with type 2 diabetes and those without the condition. Cholesterol-lowering medication will be given to participants in order to better understand how diabetes contributes to an increased risk for heart disease and stroke, even after cholesterol is reduced.

Eligible Conditions
  • Type 2 Diabetes

CHORD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up visit (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow up visit (4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in platelet activity (LTA) before and after cholesterol reduction
Change in platelet activity (MPA) before and after cholesterol reduction

CHORD Trial Design

2Treatment groups
Experimental Treatment
Group I: Type 2 Diabetes groupExperimental Treatment3 Interventions
All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Group II: Control groupExperimental Treatment3 Interventions
The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Statin
2011
Completed Phase 4
~110100
PCSK9 inhibitor
2020
Completed Phase 4
~340
Ezetimibe 10mg
2017
Completed Phase 4
~10200

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,358 Previous Clinical Trials
816,662 Total Patients Enrolled
Jeffrey Berger, MDPrincipal InvestigatorNYU Langone Health
6 Previous Clinical Trials
1,516 Total Patients Enrolled

Media Library

Ezetimibe 10mg (Cholesterol Absorption Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04369664 — Phase 4
Type 2 Diabetes Research Study Groups: Type 2 Diabetes group, Control group
Type 2 Diabetes Clinical Trial 2023: Ezetimibe 10mg Highlights & Side Effects. Trial Name: NCT04369664 — Phase 4
Ezetimibe 10mg (Cholesterol Absorption Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04369664 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for new participants in this research?

"That is correct. The listing on clinicaltrials.gov tells us that the trial coordinators are still looking for eligible candidates. The first posting was on June 22nd, 2020 with the most recent update being January 14th, 2022. They hope to have 150 enrollees from 1 location."

Answered by AI

Is this a groundbreaking clinical trial?

"There have been a total of 104 clinical trials for PCSK9 inhibitors that are still active as of now. These trials are located in 354 cities across 45 countries and the first one dates back to 2005. This initial trial, sponsored by Merck Sharp & Dohme LLC, had 80 participants and completed its Phase 4 drug approval stage. In the 16 years since then, 661 similar studies have been completed."

Answered by AI

How many individuals are being recruited for this research project?

"That is correct. The clinicaltrials.gov website shows that this trial is still looking for participants. The first posting was on June 22nd 2020 and the most recent update was January 14th 2022. So far, 1 site has enrolled 150 people."

Answered by AI

Could I qualify to be a part of this research project?

"This trial is open to adults with type 2 diabetes mellitus between the ages of 18 and 89. To date, 150 patients have been enrolled in this clinical study."

Answered by AI

For what medical conditions is PCSK9 inhibitor typically prescribed?

"A PCSK9 inhibitor is a medication that is most frequently used to lower lipid levels. However, it can also be effective in treating lipidemias, postoperative thromboembolism, and anginal pain."

Answered by AI

Do elderly citizens qualify for this clinical trial?

"In order to meet the requirements for this trial, applicants must be aged 18-89. Out of the many clinical trials available, 206 are specifically designed for children and 1262 cater to older adults."

Answered by AI

Are there other examples in the medical literature of a PCSK9 inhibitor being used?

"There are a total of 104 ongoing studies related to PCSK9 inhibitors. Of these, 24 are Phase 3 clinical trials. Many of the research centres for this topic are based in Omaha, Nebraska; though, there are 1,405 locations across the globe conducting similar investigations."

Answered by AI
~33 spots leftby Mar 2025