Phase 4
N=151
CHOlesterol Lowering and Residual Risk in Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04369664 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Percent Change in Platelet Activity (MPA) Before and After Cholesterol Reduction — -5; -7 percent change in platelet aggregation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Statin (Drug); PCSK9 inhibitor (Drug); Ezetimibe 10mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Platelet Activity (MPA) Before and After Cholesterol Reduction |
-5; -7 | — |
| PRIMARY Percent Change in Platelet Activity (LTA) Before and After Cholesterol Reduction |
-74; -76 | — |
Summary
The purpose of this study is to investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including platelet (involved in clotting) activity, inflammation, blood vessel wall function, and genetic information (blueprints of your cells), in participants with type 2 diabetes and elevated cholesterol. This study will also include a control group - subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (PCSK9 inhibitor and statin or ezetimibe) for 1 month with the same risk factors being measured following cholesterol reduction. This study will help understand why individuals with type 2 diabetes are at higher risk for heart disease and stroke before and even after cholesterol reduction.
Eligibility Criteria
Inclusion Criteria
Subjects with type 2 diabetes:
- Age ≥ 18 & 100mg/dl
- Able and willing to provide written informed consent for the study
Control subjects without known diabetes:
- Age ≥ 18 & 100mg/dl or lp(a) >50 mg/dl
- Able and willing to provide written informed consent for the study
Exclusion Criteria
Subjects with type 2 diabetes:
- Established cardiovascular disease on antithrombotic therapy
- Triglycerides >250mg/dl
- Use of a PCSK9 inhibitor
- HbA1c >10%
- Recent infection in the past 30 days
- Any hospitalization in the past 30 days
- Use of Immunosuppressive therapy
- Use of any antithrombotic therapy
- Use of aspirin
- Use of NSAID within the past 72 hours
- Pregnancy
- Anemia (hemoglobin 600)
- A history of severe bleeding or bleeding disorders
- Chronic kidney disease (CrCl < 30ml/min)
Control subjects without known diabetes:
- Diabetes (type 1 or type 2)
- All other exclusions are identical to the type 2 diabetes group.
Data sourced from ClinicalTrials.gov (NCT04369664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.