Trials / Terminated
TerminatedNCT03258281
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
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Inova Health Care Services · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
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 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.
Conditions
- Diabetes Mellitus, Type 2
- Dyslipidemia Associated With Type II Diabetes Mellitus
- Percutaneous Coronary Intervention
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Evolocumab | Patients will receive evolocumab 420 mg administered subcutaneously |
| DRUG | Placebo | Patients will receive placebo administered subcutaneously |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2019-09-01
- Completion
- 2019-10-01
- First posted
- 2017-08-23
- Last updated
- 2023-01-19
- Results posted
- 2023-01-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03258281. Inclusion in this directory is not an endorsement.