Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus (ISS-DMII)

December 22, 2022 updated by: Inova Health Care Services

Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 evolocumab therapy on platelet activation and reactivity;
  2. the effect of evolocumab on biomarkers of platelet activation and inflammation.

Eligible patients will be randomized prior to start the PCI equally to either:

  1. 420 mg evolocumab ; or
  2. placebo. The randomized treatment will be administered in subcutaneous injections.

The laboratory assessments will be performed before (baseline), and 16-24 hours and 30-days after randomization.

Subject participation will be 30 days from the randomization.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes Mellitus
  • Dyslipidemia
  • Undergoing elective PCI

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: evolocumab 420mg
75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Drug: Evolocumab
Patients will receive evolocumab 420 mg administered subcutaneously
Other Names:
  • Repatha
Placebo Comparator: placebo
75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
Drug: Placebo
Patients will receive placebo administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
Time Frame: Baseline and after 30 days of treatment
Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
Baseline and after 30 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ADP-unstimulated P-selectin Expression
Time Frame: Baseline and after 30 days of treatment
Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)
Baseline and after 30 days of treatment
Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
Time Frame: Baseline and after 30 days of treatment
Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Baseline and after 30 days of treatment
Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
Time Frame: Baseline and after 30 days of treatment
Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Baseline and after 30 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2639

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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