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

Primary Purpose

Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus, Percutaneous Coronary Intervention

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Evolocumab
Placebo
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inova Fairfax Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

evolocumab 420mg

placebo

Arm Description

75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.

75 subjects on optimal statin therapy undergoing elective PCI will receive placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
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).

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2017
Last Updated
December 22, 2022
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT03258281
Brief Title
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
Acronym
ISS-DMII
Official Title
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 (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.
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 the effect of evolocumab therapy on platelet activation and reactivity; the effect of evolocumab on biomarkers of platelet activation and inflammation. Eligible patients will be randomized prior to start the PCI equally to either: 420 mg evolocumab ; or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
evolocumab 420mg
Arm Type
Active Comparator
Arm Description
75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
Intervention Type
Drug
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
Repatha
Intervention Description
Patients will receive evolocumab 420 mg administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo administered subcutaneously
Primary Outcome Measure Information:
Title
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
Description
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).
Time Frame
Baseline and after 30 days of treatment
Secondary Outcome Measure Information:
Title
Change in ADP-unstimulated P-selectin Expression
Description
Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)
Time Frame
Baseline and after 30 days of treatment
Title
Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
Description
Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Time Frame
Baseline and after 30 days of treatment
Title
Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
Description
Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Time Frame
Baseline and after 30 days of treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

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