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

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bivalirudin; Clopidogrel; Hirudins; Ticagrelor; Ticlopidine

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) 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