Overview
Antithrombotic Effects of Ticagrelor Versus Clopidogrel
Status:
Completed
Completed
Trial end date:
2013-04-01
2013-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and bivalirudin).Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Juan J BadimonCollaborator:
AstraZenecaTreatments:
Aspirin
Bivalirudin
Clopidogrel
Hirudins
Ticagrelor
Ticlopidine
Criteria
Inclusion Criteria:- Male or female volunteers between 18 and 65 years old.
- Body mass index (BMI) 18 - 30 kg/m2 inclusive.
- Healthy as assessed by a detailed medical history and physical examination.
- Laboratory est results within the normal range.
- Ability to provide signed informed consent.
Exclusion Criteria:
- History of clinically relevant disease, bleeding, acute infectious disease or signs of
acute illness.
- Allergy or hypersensitivity to aspirin or thienopyridines, or atopy diagnosed by a
physician.
- Use of medication within one month prior to study drug administration.
- History of drug abuse or alcohol consumption >20 g/day.
- Inability to abstain from intensive muscular effort or sport competition.
- Loss of >400 mL blood or blood donation within 3 months.
- Positive serology for hepatitis B (HBs Ag) or hepatitis C.
- Conditions associated with hemorrhagic risk.
- Positive pregnancy test.