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

Phase 4

Terminated

• Conditions: Non-ST Elevation Acute Coronary Syndrome
• Interventions: Drug: clopidogrel; Drug: ticagrelor

• Registration Number: NCT02052635
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Study Start: 2014-09
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-03-08
• Results First Submitted QC: 2016-03-08
• Status Verified: 2016-04
• Results First Posted: 2016-04-06
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	clopidogrel	300 mg oral tablet
Ticagrelor	ticagrelor	90 mg oral tablet

Primary Outcome Measures

Name	Time	Method
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose	0.5 hours post 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
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose	1 hour post 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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Rapid City, South Dakota, United States