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ISS-DMII: Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Sponsor
Inova Health Care Services (Other)
Overall Status
Terminated
CT.gov ID
NCT03258281
Collaborator
(none)
31
Enrollment
1
Location
2
Arms
16
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pospective, single center, double-blind, randomised 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This is a double-blind randomized clinical trial of evolocumab versus placebo in patients with ASCVD and DM on clopidogrel and aspirin undergoing ePCI. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: evolocumab 420mg

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

Drug: Evolocumab
Patients will receive evolocumab 420 mg administered subcutaneously
Other Names:
  • Repatha

    		•
    Placebo Comparator: placebo

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

    Drug: Placebo
    Patients will receive placebo administered subcutaneously

    Outcome Measures

    Primary Outcome Measures

    1. Absolute difference in ADP-stimulated P-selectin expression [30 Days]

      Absolute difference in ADP-stimulated P-selectin expression 30 days post-dose in between patients treated with clopidogrel plus evolocumab therapy and clopidogrel plus placebo therapy for 30 days. First absolute difference in p-selectin expression between baseline and 30 days post-dose will be calculated in each group followed by estimation of absolute difference between the two groups.

    Secondary Outcome Measures

    1. Absolute differences in unstimulated and ADP-stimulated p-selectin and GPIIb/IIIa receptor expression and unstimulated CD36, and LOX-1 [30 Days]

      • Absolute differences in unstimulated and ADP-stimulated (except 30 day times point, primary endpoint) p-selectin and GPIIb/IIIa receptor expression and unstimulated CD36, and LOX-1 measured at baseline and 16-24 hours and 30-day post-randomization in patients treated with clopidogrel plus evolocumab therapy and clopidogrel plus placebo therapy.

    2. Absolute differences in lipid profile including LDL-C, oxLDL, fibrinogen [30 Days]

      • Absolute differences in lipid profile including LDL-C, oxLDL, fibrinogen, hsCRP, p-selectin, atherox (soluble markers) measured at baseline and 16-24 hours and 30-day post-randomization in patients treated with clopidogrel plus evolocumab therapy and clopidogrel plus placebo therapy.

    3. Prevalence of high on-clopidogrel platelet reactivity by the VerifyNow P2Y12 assa [30 Days]

      Prevalence of high on-clopidogrel platelet reactivity by the VerifyNow P2Y12 assay measured at baseline, and 16-24 hours and 30-day post randomization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inova Fairfax Hospital Falls Church Virginia United States 22042

    Sponsors and Collaborators

    • Inova Health Care Services

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT03258281
    Other Study ID Numbers:
    • 17-2639
    First Posted:
    Aug 23, 2017
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Dyslipidemias
    Evolocumab

    Study Results

    No Results Posted as of Mar 31, 2022