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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00642811

Purpose

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.

Condition	Intervention	Phase
Stable Coronary Artery Disease	Drug: AZD6140 Drug: Clopidogrel Drug: Aspirin	Phase II

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the effect of AZD6140 on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel. [ Designated as safety issue: No ]

Secondary Outcome 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 [ Designated as safety issue: No ]
To assess the overall safety and tolerability of AZD6140 compared to clopidogrel and placebo [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aspirin + AZD6140	Drug: AZD6140 oral tablet Drug: Aspirin oral
2: Active Comparator Aspirin + Clopidogrel	Drug: Clopidogrel oral Drug: Aspirin oral

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642811

Contacts

Contact: AstraZeneca Clinical Study Information

1-800-236-9933

information.center@astrazeneca.com

Locations

United States, Maryland
Research Site	Recruiting
Baltimore, Maryland, United States
United States, Ohio
Research Site	Not yet recruiting
Cincinnati, Ohio, United States
United States, Texas
Research Site	Not yet recruiting
San Antonio, Texas, United States
Canada, Alberta
Research Site	Not yet recruiting
Edmonton, Alberta, Canada
Canada, Ontario
Research Site	Not yet recruiting
Hamilton, Ontario, Canada
Canada, Quebec
Research Site	Not yet recruiting
Montreal, Quebec, Canada
Denmark
Research Site	Not yet recruiting
Esbjerg, Denmark
Research Site	Not yet recruiting
Aalborg, Denmark
Research Site	Not yet recruiting
Arhus, Denmark
France
Research Site	Not yet recruiting
Marseille cedex 15, France
Hungary
Research Site	Not yet recruiting
Balatonfured, Hungary
Research Site	Not yet recruiting
Debrecen, Hungary
United Kingdom
Research Site	Not yet recruiting
Sheffield, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jay Horrow, MD	AstraZeneca
Principal Investigator:	Paul Gurbel, md	Platelet & Thrombosis Research, LLC

More Information

Responsible Party:	AstraZeneca ( Jay Horrow - Medical Science DIrector )
Study ID Numbers:	D5130C00030
Study First Received:	March 19, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00642811
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

coronary artery disease (CAD)
heart attack
stable angina

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Aspirin
Clopidogrel
Myocardial Ischemia

Vascular Diseases
Angina Pectoris
Arteriosclerosis
Ischemia
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:

Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009