Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Phase 4

Terminated

• Conditions: Diabetes Mellitus, Type 2; Percutaneous Coronary Intervention; Dyslipidemia Associated With Type II Diabetes Mellitus
• Interventions: Drug: Evolocumab; Drug: Placebo

• Registration Number: NCT03258281
• Lead Sponsor: Inova Health Care Services

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

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 Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-23
• Study Start: 2018-05-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-10-01
• Status Verified: 2022-12
• Results First Submitted: 2022-12-02
• Results First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Results First Posted: 2023-01-19
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Diabetes Mellitus
• Dyslipidemia
• Undergoing elective PCI

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
evolocumab 420mg	Evolocumab	75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
placebo	Placebo	75 subjects on optimal statin therapy undergoing elective PCI will receive placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in ADP-unstimulated P-selectin Expression	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)
Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)	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)
Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI	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)

Trial Locations

Locations (1)

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States