A Study of the Onset and Offset of Antiplatelet Effects Comparing AZD6140, Clopidogrel, and Placebo With Aspirin
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: AZD6140 (Drug); Clopidogrel (Drug); aspirin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Philip Sager, MD, Study Director, Affiliation: AstraZeneca
Paul Gurbel, MD, Principal Investigator, Affiliation: Platelet & Thrombosis Research, LLC
Overall contact:
AstraZeneca Clinical Study, Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
Summary
The purpose of this study is to see how AZD6140, a new oral reversible anti-platelet
medication, affects platelets. Anti-platelet agents are medications that block the formation
of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding,
but when they form inside the arteries their formation is linked to a risk of medical
problems such as heart attack and stroke. This study will investigate how long it takes for
AZD6140 to begin working and how long it takes for it to stop working after the last dose of
drug. AZD6140 will be compared to clopidogrel, an established anti-platelet treatment for
preventing blood clots, and placebo plus aspirin.
Clinical Details
Official title: A Multi-Centre Randomised, Double-Blind, Double-Dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of AZD6140 Compared With Clopidogrel and Placebo With Aspirin as Background Therapy in Patients With Stable Coronary Artery Disease (CAD)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: To determine the onset and offset of antiplatelet effect of AZD6140 compared to clopidogrel by evaluation of the % IPA by LTA and by evaluation of the difference in slope of IPA effect curve by LTA
Secondary outcome: To evaluate the PK/PD relationship of AZD6140 and its active metabolite; to determine the effect on platelet aggregation of AZD6140 compared to clopidogrel; to assess the overall safety and tolerability of AZD6140 compared to clopidogrel and placebo
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Documented stable Coronary Artery Disease (stable angina, previous MI history,
previous history of revascularization);
- Females of child bearing potential must have a negative pregnancy test prior to
receiving study drug and be willing to use a hormonal contraceptive in addition to
double barrier contraception
Exclusion Criteria:
- History of Acute Coronary Syndromes within 12 months of screening or need for
revascularization (angioplasty or CABG)
- History of liver or kidney disease
- Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high
blood pressure, low platelet count, recent major trauma
- History of intolerance or allergy to aspirin or clopidogrel
Locations and Contacts
AstraZeneca Clinical Study, Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
Research Site, Sheffield, United Kingdom; Recruiting
Research Site, Baton Rouge, Louisiana, United States; Recruiting
Research Site, Baltimore, Maryland, United States; Recruiting
Research Site, Towson, Maryland, United States; Recruiting
Research Site, Cincinnati, Ohio, United States; Recruiting
Research Site, Oklahoma City, Oklahoma, United States; Recruiting
Research Site, Philadelphia, Pennsylvania, United States; Not yet recruiting
Research Site, Rapid City, South Dakota, United States; Recruiting
Research Site, Houston, Texas, United States; Not yet recruiting
Additional Information
Starting date: October 2007
Ending date: February 2009
Last updated: October 7, 2008
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