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 range18 Years – 130 Years
SexALL
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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…
What they're measuring
1
P2Y12 Reaction Units (PRU) Using VerifyNowâ„¢ at 0.5 Hours After Loading Dose
Timeframe: 0.5 hours post loading dose
2
P2Y12 Reaction Units (PRU) Using VerifyNowâ„¢ at 1 Hour After Loading Dose