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Statins

Cholesterol-Lowering Drugs for Type 1 Diabetes (CHORD1 Trial)

Phase 4

Recruiting

Led By Ira Goldberg, 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

Meeting at least 1 of the following American Diabetes Association Criteria for diagnosis of diabetes: FPG ≥126 mg/dL (7.0 mmol/L), 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT, A1C ≥6.5%, or random plasma glucose ≥200 mg/dL (11.1 mmol/L) with classic symptoms of hyperglycemia or hyperglycemic crisis

Age ≥ 18 & < 90

Must not have

Established cardiovascular disease on antithrombotic therapy

Chronic kidney disease (CrCl < 30ml/min)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will look at how reducing cholesterol affects platelets, WBCs & blood vessels in people with T1D.

Who is the study for?

This trial is for adults aged 18 to 89 with Type 1 Diabetes and LDL cholesterol over 100mg/dl. They must have a confirmed diagnosis of T1D, not be pregnant, and cannot have been hospitalized or had an infection in the last month. Participants should not be on aspirin, NSAIDs within the past three days, immunosuppressives, antithrombotics, or PCSK9 inhibitors.

What is being tested?

The study tests how lowering cholesterol affects platelet function (which helps blood clot), White Blood Cell gene expression (important for fighting infections), and blood vessel function in people with Type 1 Diabetes using Evolocumab Cartridge combined with Atorvastatin Calcium Tablets or Ezetimibe Tablets.

What are the potential side effects?

Potential side effects may include injection site reactions from Evolocumab Cartridge; muscle pain, weakness from Atorvastatin Calcium; stomach pain from Ezetimibe Tablets. The severity of side effects can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diabetes based on blood sugar or A1C levels.

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I am between 18 and 89 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on medication to prevent blood clots due to heart disease.

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My kidney function is severely reduced.

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I am taking a PCSK9 inhibitor medication.

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I have type 2 diabetes or a genetic diabetes condition, or my diabetes is due to a pancreatic disease.

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I have a history of bleeding disorders.

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I have not been hospitalized in the last 30 days.

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I am currently taking aspirin.

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I am currently taking medication to prevent blood clots.

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I am currently taking medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Light Transmission Aggregation (LTA) from Baseline

Change in Monocyte Platelet Aggregation (MPA) from Baseline

Secondary study objectives

Percent Change in CD8 Cell Population from Baseline

Percent Change in Dendritic Cell Population from Baseline

Percent Change in Natural Killer (NK) Cell Population from Baseline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 4-Week LDL-Cholesterol (LDL-C)-Reduction TreatmentExperimental Treatment7 Interventions

Treatment consists of: Evolocumab (140 mg; 2 injections, one administered at baseline visit and another self-administered 2 weeks later), and; Atorvastatin (up to 80mg dose; 1 tab per day for 30 days, starting at baseline visit post-assessment). Participants with statin intolerance will be provided with a 1-month supply of ezetimibe 10 mg to replace Evolocumab and Atorvastatin. * Additional procedures: Blood draws. * Optional procedures: Glycocalyx testing, PET/CT, or Endothelial Cell Collection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atorvastatin Calcium Tablets

2022

Completed Phase 4

~400

18F-FDG

2017

Completed Phase 4

~750