A Study of the Antiplatelet Effects Comparing AZD6140 With Clopidogrel Responder and Non-Responders

Condition(s) targeted: Stable 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):
Jay Horrow, 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

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.

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]

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

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

Secondary outcome:

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

To assess the overall safety and tolerability of AZD6140 compared to clopidogrel and placebo

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Research Site, Esbjerg, Denmark; Not yet recruiting

Research Site, Aalborg, Denmark; Not yet recruiting

Research Site, Arhus, Denmark; Not yet recruiting

Research Site, Marseille cedex 15, France; Not yet recruiting

Research Site, Balatonfured, Hungary; Not yet recruiting

Research Site, Debrecen, Hungary; Not yet recruiting

Research Site, Sheffield, United Kingdom; Not yet recruiting

Research Site, Edmonton, Alberta, Canada; Not yet recruiting

Research Site, Baltimore, Maryland, United States; Recruiting

Research Site, Cincinnati, Ohio, United States; Not yet recruiting

Research Site, Hamilton, Ontario, Canada; Not yet recruiting

Research Site, Montreal, Quebec, Canada; Not yet recruiting

Research Site, San Antonio, Texas, United States; Not yet recruiting

Starting date: May 2008
Ending date: February 2009
Last updated: October 9, 2008