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Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention (ISS-DMII)

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ClinicalTrials.gov Identifier: NCT03258281
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

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
Diabetes Mellitus, Type 2 Dyslipidemia Associated With Type II Diabetes Mellitus Percutaneous Coronary Intervention Drug: Evolocumab Drug: Placebo Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

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 Name: Repatha

Placebo Comparator: placebo
75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
Drug: Placebo
Patients will receive placebo administered subcutaneously




Primary Outcome Measures :
  1. Absolute difference in ADP-stimulated P-selectin expression [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258281


Contacts
Contact: Kevin Bliden, BS/MBA 703-776-7702 kevin.bliden@inova.org

Locations
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Kevin Bliden, BS/MBA    703-776-7702    kevin.bliden@inova.org   
Sponsors and Collaborators
Inova Health Care Services

Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03258281     History of Changes
Other Study ID Numbers: 17-2639
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: January 2018

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs