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

• Status: Terminated
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inova Health Care Services
• Treatments: Evolocumab

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