Official Title: “A Randomised, Double-Blind, Outpatient, Crossover Study of theAnti-Platelet Effects of AZD6140 Compared With Clopidogrel in Patients With Stable Coronary Artery Disease Previously Identified as Clopidogrel Non-Responders or Responders [RESPOND]”

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 the effect of AZD6140 on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel.

Study Type: Interventional

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

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: AZD6140
  • oral tablet
• Drug: Clopidogrel
  • oral
• Drug: Aspirin
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Aspirin + AZD6140
• Active Comparator: 2
  • Aspirin + Clopidogrel

Primary Measures

• To assess the effect of AZD6140 on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel.
  • Safety Issue?: No

Secondary Measures

• To compare inhibition of platelet aggregation (IPA), platelet aggregation and biomarker expression in clopidogrel responsive patients when directly switched from clopidogrel to AZD6140, in addition, also when switching from AZD6140 to Clopidogrel
  • Safety Issue?: No
• To assess the overall safety and tolerability of AZD6140 compared to clopidogrel and placebo
  • Safety Issue?: Yes

Inclusion Criteria:

• Patients with documented stable Coronary Artery Disease (CAD) (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)
• Any acute or chronic unstable condition in the past 30 days
• 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

Jay Horrow, MD Study Director AstraZeneca  

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

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642811

Study ID Number: D5130C00030

ClinicalTrials.gov Identifier: NCT00642811

Health Authority: United States: Food and Drug Administration