Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during PCI on a background therapy of aspirin in patients with NSTE-ACS.

Official Title
-----------------
A Phase IV, Randomised, Multi-Centre, Open Label Study, Comparing Ticagrelor Versus Clopidogrel in Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI) With Bivalirudin

Conditions
-----------------
Non-ST Elevation Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: ticagrelor
* Drug: clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
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 intracranial bleed. Use of Intravenous (IV) heparin less than 2 hours before procedure. Sustained uncontrolled high blood pressure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br>90 mg oral tablet | Drug: ticagrelor<br>* Single loading dose of 180mg of ticagrelor at time of bivalirudin administration. Beginning 12 hrs following study drug administration, all pts in the ticagrelor arm will receive ticagrelor 90 mg (maintenance dose) approximately every 12 hrs until Follow-up telephone contact.<br>* Other names: Brilinta;|
| Active Comparator: Clopidogrel<br>300 mg oral tablet | Drug: clopidogrel<br>* Single loading oral dose of 600 mg of clopidogrel will be given at time of bivalirudin administration. Beginning 4 hrs following study drug administration, all pts in the clopidorgrel arm will receive ticagrelor 180 mg for the loading dose, followed by 90 mg maintenance dose approximately every 12 hours until the Follow-up telephone contact.<br>* Other names: Plavix;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose | PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus | 0.5 hours post loading dose | 
| P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose | PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus | 1 hour post loading dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous Coronary Intervention