Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus (NCT03258281) | Clinical Trial Compass
TerminatedPhase 4
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
Stopped: Low enrollment
United States4 participantsStarted 2018-05-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
Timeframe: Baseline and after 30 days of treatment