Official Title: “A Randomised, Double-Blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]”

AZD6140 is a new, reversible, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. AZD6140 is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. AZD6140 will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: AZD6140
  • oral treatment
• Drug: Clopidogrel
  • oral treatment

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• The primary outcome measure will be the reduction in the relative risk of vascular death, nonfatal myocardial infarction, or nonfatal stroke (composite primary endpoint), comparing AZD6140 to clopidogrel in patients with non-ST or ST elevation ACS.
  • Time Frame: assessed after treatment
    Safety Issue?: Yes

Secondary Measures

• Secondary outcomes will include the individual event categories from the primary composite endpoint, a variety of other important clinical outcomes related to ACS, and assessment of the overall safety and tolerability of AZD6140 compared to clopidogrel.
  • Time Frame: assessed after treatment
    Safety Issue?: No

Inclusion Criteria:

• Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
• Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria:

• Persons with moderate or severe liver disease
• Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
• Persons who are being treated with blood clotting agents that cannot be stopped

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

Robert Harrington, MD Principal Investigator Duke University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00391872

Study ID Number: D5130C05262

ClinicalTrials.gov Identifier: NCT00391872

Health Authority: United States: Food and Drug Administration