Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

— ISS-DMII  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03258281
• Other study ID #: 17-2639
• Status: Terminated
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

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

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