Clinical trial NCT02052635: Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Non-ST Elevation Acute Coronary Syndrome
Keywords: Percutaneous Coronary Intervention
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
timeFrame: 0.5 hours post loading dose
measure: P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
timeFrame: 1 hour post loading dose
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Lake Mary
country: United States
facility: Research Site
state: Florida
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
Study officials:
affiliation: Newark Beth Israel Medical Center
name: Marc Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: