NCT03258281

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 19, 2023

Completed
Last Updated

January 19, 2023

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

June 29, 2017

Results QC Date

December 2, 2022

Last Update Submit

December 22, 2022

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in ADP-unstimulated P-selectin Expression

    Baseline and after 30 days of treatment

  • 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 Cluster of Differentiation (CD)-147 MFI

    Baseline and after 30 days of treatment

Study Arms (2)

evolocumab 420mg

ACTIVE COMPARATOR

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

Drug: Evolocumab

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EvolocumabDRUG

Patients will receive evolocumab 420 mg administered subcutaneously

Also known as: Repatha
evolocumab 420mg
PlaceboDRUG

Patients will receive placebo administered subcutaneously

placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes Mellitus
  • Dyslipidemia
  • Undergoing elective PCI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Study was terminated early as a result of 1) low enrollment and , 2) thrombosis research center moving to another health system (LifeBridge Health) . Only 4 patients were enrolled, as a result we were not able to conduct an analysis on any of the endpoints.

Results Point of Contact

Title
Director of Clinical Trials
Organization
Sinai Center for Thrombosis Research
kpbliden@gmail.com
443-244-1497

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2017

First Posted

August 23, 2017

Study Start

May 1, 2018

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

January 19, 2023

Results First Posted

January 19, 2023

Record last verified: 2022-12

Locations

US(1)