A Study of the Antiplatelet Effects Comparing Ticagrelor (ticag. - AZD6140) with Clopidogrel (Clop.) Responder and Non-responders - RESPOND
Study identifier:D5130C00030
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double-Blind, Outpatient, Crossover Study of the Anti-platelet Effects of Ticagrelor Compared with Clopidogrel in Patients with Stable Coronary Artery Disease Previously Identified as Clopidogrel Non-responders or Responders [RESPOND]
Medical condition
Stable coronary artery disease
Phase
Phase 2
Healthy volunteers
No
Study drug
Ticagrelor, Clopidogrel, Aspirin
Sex
All
Actual Enrollment
98
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 May 2008
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Mar 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Aspirin + Ticagrelor | Drug: Ticagrelor Tablets, Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily for 2 weeks 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 |
| Active Comparator: 2 Aspirin + Clopidogrel | Drug: Clopidogrel (over encapsulated) capsule, Oral, 75 mg; 600 mg loading dose followed by 75 mg once daily for 2 weeks Other Name: Plavix 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 |
Contacts
Investigators
Principal Investigator
Jay Horrow
AstraZeneca
