Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention

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.

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.

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