A Comparison of AZD6140 and Clopidogrel in Patients With Acute Coronary Syndrome

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.

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)

Conditions

Acute Coronary Syndrome

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome 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.

Secondary Outcome 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.

Study Start

September 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

18000

Contact Details

AstraZeneca Clinical Study Information

• information.center@astrazeneca.com
• Outside US: 001-800-236-9933

Australian Locations

• Research Site, BRUCE, Australia; Not yet recruiting
• Research Site, CHERMSIDE, Australia; Not yet recruiting
• Research Site, HERSTON, Australia; Not yet recruiting
• Research Site, WOOLLOONGABBA, Australia; Not yet recruiting
• Research Site, BEDFORD PARK, Australia; Not yet recruiting
• Research Site, DANDENONG, Australia; Not yet recruiting
• Research Site, GEELONG, Australia; Not yet recruiting
• Research Site, PRAHAN, Australia; Not yet recruiting
• Research Site, PERTH, Australia; Not yet recruiting

All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.