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: 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
Study Completion Date:	March 2009
Primary Completion Date:	March 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

Locations

United States, Arkansas
Research Site
Jonesboro, Arkansas, United States
United States, Florida
Research Site
Ormond Beach, Florida, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Canada
Research Site
Lachine, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Denmark
Research Site
Esbjerg, Denmark
Research Site
Aalborg, Denmark
Research Site
Arhus, Denmark
United Kingdom
Research Site
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

No publications provided

Responsible Party:	AstraZeneca ( Jay Horrow - Medical Science DIrector )
Study ID Numbers:	D5130C00030
Study First Received:	March 19, 2008
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00642811 History of Changes
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
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Ischemia
Arteriosclerosis

Coronary Disease
Aspirin
Clopidogrel
Platelet Aggregation Inhibitors
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions

Coronary Disease
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009