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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: AZD6140
  • oral tablet
• Drug: Clopidogrel
  • 75 mg once daily oral dosage
• Drug: aspirin
  • 325 mg oral tablet once daily dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Aspirin therapy + Placebo
• Active Comparator: 2
  • Aspirin + clopidogrel
• Experimental: 3
  • Aspirin + AZD6140

Primary Measures

• 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
  • Time Frame: Assessed 2 hrs post 1st dose of drug and after the last dose of drug
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: Assessed at each visit
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Philip Sager, MD Study Director AstraZeneca  

Overall Contact: AstraZeneca Clinical Study, Information 1-800-236-9933 information.center@astrazeneca.com

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00528411

Study ID Number: D5130C00048

ClinicalTrials.gov Identifier: NCT00528411

Health Authority: United States: Food and Drug Administration