A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo with Aspirin
Study identifier:D5130C00048
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multi-centre Randomised, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of Ticagrelor Compared with Clopidogrel and Placebo With Aspirin as Background Therapy in Patients with Stable Coronary Artery Disease (CAD)
Medical condition
Coronary artery disease
Phase
Phase 2
Healthy volunteers
No
Study drug
Ticagrelor Tablets, Clopidogrel (over encapsulated) capsule, Aspirin Tablets
Sex
All
Actual Enrollment
123
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Mar 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Aspirin + Placebo | Drug: Aspirin Tablets Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study. Other Name: ASA |
| Active Comparator: 2 Aspirin + clopidogrel | Drug: Clopidogrel (over encapsulated) capsule Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD) Other Name: Plavix Other Name: Clopidogrel Bisulfate Drug: Aspirin Tablets Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study. Other Name: ASA |
| Experimental: 3 Aspirin + Ticagrelor | Drug: Ticagrelor Tablets Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD) Drug: Aspirin Tablets Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study. Other Name: ASA |
Contacts
Investigators
Principal Investigator
Philip Sager
AstraZeneca
