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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03258281
Other study ID # 17-2639
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 1, 2018
Est. completion date October 1, 2019

Study information

Verified date December 2022
Source Inova Health Care Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date October 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Evolocumab
Patients will receive evolocumab 420 mg administered subcutaneously
Placebo
Patients will receive placebo administered subcutaneously

Locations

Country Name City State
United States Inova Fairfax Hospital Falls Church Virginia

Sponsors (1)

Lead Sponsor Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline and after 30 days of treatment
Secondary 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) Baseline and after 30 days of treatment
Secondary 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) Baseline and after 30 days of treatment
Secondary 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) Baseline and after 30 days of treatment
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