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

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ClinicalTrials.gov Identifier: NCT02052635
Recruitment Status : Terminated (Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe)
First Posted : February 3, 2014
Results First Posted : April 6, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-ST Elevation Acute Coronary Syndrome Drug: ticagrelor Drug: clopidogrel Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ticagrelor
90 mg oral tablet
 Drug: ticagrelor
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.
Other Name: Brilinta
Active Comparator: Clopidogrel
300 mg oral tablet
 Drug: clopidogrel
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.
Other Name: Plavix


Outcome Measures
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Primary Outcome Measures :
  1. P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose [ Time Frame: 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

  2. P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052635


Locations
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United States, Florida
Research Site
Jacksonville, Florida, United States
Research Site
Lake Mary, Florida, United States
United States, Georgia
Research Site
Macon, Georgia, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Site
Hershey, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
United States, South Dakota
Research Site
Rapid City, South Dakota, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Marc Cohen, MD Newark Beth Israel Medical Center
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02052635    
Other Study ID Numbers: D5130L00065
First Posted: February 3, 2014    Key Record Dates
Results First Posted: April 6, 2016
Last Update Posted: May 27, 2016
Last Verified: April 2016
Keywords provided by AstraZeneca:
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
 Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs