Status:
TERMINATED
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
Lead Sponsor:
Inova Health Care Services
Conditions:
Diabetes Mellitus, Type 2
Dyslipidemia Associated With Type II Diabetes Mellitus
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and Diabetes Mellitus ...
Detailed Description
This is a double-blind randomized clinical trial of evolocumab versus placebo in patients with ASCVD and DM on clopidogrel and aspirin undergoing PCI. The study is aimed to assess 1. the effect of ev...
Eligibility Criteria
Inclusion
- Diabetes Mellitus
- Dyslipidemia
- Undergoing elective PCI
Exclusion
- Patients with recent Acute Coronary Syndrome (≤1 month)
- Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel
- Patients undergoing urgent/emergent PCI for stent thrombosis
- Severe acute or chronic medical or psychiatric condition
- Pregnancy
- Participation in another experimental clinical trial, without formal approval
- Unwillingness or inability to comply with the requirements of this protocol
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03258281
Start Date
May 1 2018
End Date
October 1 2019
Last Update
January 19 2023
Active Locations (1)
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1
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042