Overview

Antithrombotic Effects of Ticagrelor Versus Clopidogrel

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Juan J Badimon
Collaborator:
AstraZeneca
Treatments:
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.