Status:
COMPLETED
CHOlesterol Lowering and Residual Risk in Type 2 Diabetes
Lead Sponsor:
NYU Langone Health
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief 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 stro...
Detailed Description
As part of this SFRN investigating REPAIR (non-progression of clinical events or regression of atherosclerosis) in T2D, this project will reveal mechanisms behind the platelet mediated increased cardi...
Eligibility Criteria
Inclusion
- Subjects with type 2 diabetes:
- Age ≥ 18 \& \< 90
- LDL-C \>100mg/dl
- Able and willing to provide written informed consent for the study
- Control subjects without known diabetes:
- Age ≥ 18 \& \< 90
- LDL-C \>100mg/dl or lp(a) \>50 mg/dl
- Able and willing to provide written informed consent for the study
Exclusion
- 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 \< 9 g/dl) or thrombocytopenia (Platelet count \<75), or thrombocytosis (Platelet count \>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.
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2023
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04369664
Start Date
August 12 2020
End Date
October 19 2023
Last Update
October 17 2024
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016