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.