TerminatedPhase 4

Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Stopped: Low enrollment

United States4 participantsStarted 2018-05-01

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression

Timeframe: Baseline and after 30 days of treatment

Trial details

NCT IDNCT03258281

SponsorInova Health Care Services

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-01

Results submitted2022-12-02

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials