NSAIDs vs. Coxibs in the Presence of Aspirin (NCT03699293) | Clinical Trial Compass
TerminatedPhase 4
NSAIDs vs. Coxibs in the Presence of Aspirin
Stopped: Our group moved from Inova Heart and Vascular institute to Sinai Hospital with Platelet and Thrombosis, LLC taking over sponsorship. Study was then IRB approved at Sinai on March, 2020 but closed prior to any additional enrolment due to COVID.
United States8 participantsStarted 2018-09-22
Plain-language summary
The objectives of this single site, randomized, crossover study is to evaluate the pharmacodynamic interactions between aspirin, NSAIDs and Coxibs with respect to platelet function, biomarkers of inflammation and endothelial function.
Who can participate
Age range
18 Years – 75 Years
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
. Age 18-75 years of age for patients who regularly use NSAIDs.
. Age 18-65 years of age for patients who do not regularly use NSAIDs
. Able to give informed consent
. Subjects with CVD or increased CV risk. Please see definitions for each criteria below:
. Planned coronary, cerebrovascular, or peripheral revascularization
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 in Arachidonic Acid (AA)-Induced Platelet Aggregation
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment period
2
Change in Collagen-induced Platelet Aggregation (%)
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment period
3
Change in Adenosine Diphosphate (ADP)-Induced Platelet Aggregation (%)
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.
4
Change in Epinephrine-induced Platelet Aggregation (%)
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.