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

AstraZeneca

Status and phase

Terminated

Phase 4

Conditions

Non-ST Elevation Acute Coronary Syndrome

Treatments

Drug: clopidogrel

Drug: ticagrelor

Study type

Interventional

Funder types

Industry

Identifiers

NCT02052635

D5130L00065

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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