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

Inova Health Care Services

Status and phase: Terminated; Phase 4

Conditions: Percutaneous Coronary Intervention; Diabetes Mellitus, Type 2; Dyslipidemia Associated With Type II Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Evolocumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03258281

17-2639

Details and patient eligibility

About

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.

Full description

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

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

evolocumab 420mg

Active Comparator group

Description:

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

Treatment:

Drug: Evolocumab

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo