Ticagrelor vs clopidogrel in non-ST elevation acute coronary syndrome patients undergoing PCI with bivalirudin. - NSTE-ACS
Study identifier:D5130L00065
ClinicalTrials.gov identifier:NCT02052635
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
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
Medical condition
Non-ST elevation Acute Coronary Syndrome
Phase
Phase 4
Healthy volunteers
No
Study drug
ticagrelor, clopidogrel
Sex
All
Actual Enrollment
34
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 01 Sept 2014
Primary Completion Date: 01 Apr 2015
Study Completion Date: 01 Apr 2015
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 |
Contacts
Investigators
Principal Investigator
Marc Cohen
Newark Beth Israel Medical Center
