Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | High Cholesterol, Diabetes, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/21/2019 |
| Start Date: | May 1, 2018 |
| End Date: | December 1, 2019 |
| Contact: | Kevin Bliden, BS/MBA |
| Email: | kevin.bliden@inova.org |
| Phone: | 703-776-7702 |
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.
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 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.
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.
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
We found this trial at
1
site
3300 Gallows Road
Falls Church, Virginia 22042
Falls Church, Virginia 22042
(703) 776-4001
Phone: 703-776-7702
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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