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

Primary Purpose

Non-ST Elevation Acute Coronary Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ticagrelor
clopidogrel
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST Elevation Acute Coronary Syndrome focused on measuring Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

90 mg oral tablet

300 mg oral tablet

Outcomes

Primary Outcome Measures

P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After 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
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

Secondary Outcome Measures

Full Information

First Posted
January 14, 2014
Last Updated
April 28, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02052635
Brief Title
Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.
Acronym
NSTE-ACS
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Elevation Acute Coronary Syndrome
Keywords
Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
90 mg oral tablet
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
300 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
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.
Primary Outcome Measure Information:
Title
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
Description
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
Time Frame
0.5 hours post loading dose
Title
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
Description
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
Time Frame
1 hour post loading dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Cohen, MD
Organizational Affiliation
Newark Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Lake Mary
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
Country
United States

12. IPD Sharing Statement

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

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