Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI Wit… (NCT02052635) | Clinical Trial Compass
TerminatedPhase 4
Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.
Stopped: Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe
United States34 participantsStarted 2014-09
Plain-language summary
The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin.
Who can participate
Age range
18 Years – 130 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:
* Hospitalised for chest pain and potential acute coronary syndrome.
* Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
* Females must be either surgically sterile or post-menopausal.
* Activated Clotting Time (ACT) \</= 300 at the time of study treatment
Exclusion Criteria:
* Participation in another clinical study with an investigational product during the last 30 days.
* Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
* Any contraindication to ticagrelor, clopidogrel or bivalirudin.
* ST elevation myocardial infraction within 24 hours of study entry.
* Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
* Planned use of omeprazole or esomeprazole.
* Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication.
* Patients with known bleeding diathesis or coagulation disorder; history of i…
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
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
Timeframe: 0.5 hours post loading dose
2
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose