A Comparison of AZD6140 and Clopidogrel in Patients With Acute Coronary Syndrome - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00391872

Purpose

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.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: AZD6140 Drug: Clopidogrel	Phase III

MedlinePlus related topics: Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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

Further study details as provided by AstraZeneca:

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. [ Time Frame: assessed after treatment ] [ Designated as safety issue: Yes ]

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. [ Time Frame: assessed after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	18000
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Clopidogrel	Drug: Clopidogrel oral treatment
2: Experimental AZD6140	Drug: AZD6140 oral treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391872

Show 742 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Robert Harrington, MD	Duke University
Principal Investigator:	Lars Wallentin, MD	Uppsala Clinical Research Centre
Study Director:	Jonathan C. Fox, MD	AstraZeneca

More Information

Publications indexed to this study:

[No authors listed] Molecule of the month. Ticagrelor. Drug News Perspect. 2007 May;20(4):264. No abstract available.

Study ID Numbers:	D5130C05262, PLATO
Study First Received:	October 23, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00391872
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

ACS
Acute coronary syndrome
Heart attack
Unstable angina
Coronary artery disease

Study placed in the following topic categories:

Coronary Disease
Heart Diseases
Clopidogrel
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases

Angina Pectoris
Ischemia
Angina, Unstable
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:

Pathologic Processes
Disease
Therapeutic Uses
Syndrome

Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009