Status:
COMPLETED
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Scott R. MacKenzie Foundation
Conditions:
Chronic Kidney Disease (CKD)
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with diabetes mellitus (DM) and chronic kidney disease (CKD) are at increased risk of atherothrombotic events. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor in patient...
Detailed Description
Patients with diabetes mellitus (DM) and coexisting chronic kidney disease (CKD) are at increased risk of atherothrombotic events, underscoring the importance of secondary prevention antiplatelet ther...
Eligibility Criteria
Inclusion
- Type 2 DM, defined according to ADA definition, on treatment with oral hypoglycemic agents and/or insulin
- Angiographically documented CAD
- On treatment with low-dose aspirin (81mg/day) for ≥30 days as part of standard of care.
Exclusion
- Use of any antiplatelet therapy (except aspirin) in prior 30 days
- Use of parenteral or oral anticoagulation
- Active bleeding
- High risk of bleeding
- Clinical indication to be on a P2Y12 receptor inhibitor
- End-stage renal disease on hemodialysis
- Any active malignancy
- Platelet count \< 100x106/µl
- Hemoglobin \<9 g/dl
- Severe known liver disease
- Hemodynamic instability
- Known allergy to clopidogrel
- Pregnant / lactating females (women of childbearing age must use reliable birth control).
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03774394
Start Date
August 22 2019
End Date
May 31 2022
Last Update
August 21 2023
Active Locations (1)
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1
University of Florida Jacksonville
Jacksonville, Florida, United States, 32209