Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.
Condition: Non-ST Elevation Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: ticagrelor; clopidogrel
Intervention description: 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.; 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.
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Percutaneous Coronary Intervention

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.
    

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