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Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

NCT03258281 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-01-19

Study results available
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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.

Conditions

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

Interventions

DRUG

Evolocumab

Patients will receive evolocumab 420 mg administered subcutaneously

DRUG

Placebo

Patients will receive placebo administered subcutaneously

Sponsors & Collaborators

  • Inova Health Care Services

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-09-01
Completion
2019-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258281 on ClinicalTrials.gov