Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT03258281
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Patients will receive evolocumab 420 mg administered subcutaneously
  • Placebo — DRUG
    Patients will receive placebo administered subcutaneously

Study Details

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 (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2) placebo.

Key Dates

Start date
May 1, 2018
Status verified
Dec 2022
Primary completion
Sep 1, 2019
Completion
Oct 1, 2019

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: evolocumab 420mg
    75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
  • Placebo Comparator: placebo
    75 subjects on optimal statin therapy undergoing elective PCI will receive placebo

Primary Outcome Measure

Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression [ Time Frame: Baseline and after 30 days of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax HospitalFalls ChurchVirginia22042-

Find similar trials in Falls Church, VA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Inova Fairfax Hospital· Falls Church, VA

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