A Study of the Onset and Offset of Antiplatelet Effects Comparing AZD6140, Clopidogrel, and Placebo With Aspirin - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00528411

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 how long it takes for AZD6140 to begin working and how long it takes for it to stop working after the last dose of drug. AZD6140 will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus aspirin.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: AZD6140 Drug: Clopidogrel Drug: aspirin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Multi-Centre Randomised, Double-Blind, Double-Dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of AZD6140 Compared With Clopidogrel and Placebo With Aspirin as Background Therapy in Patients With Stable Coronary Artery Disease (CAD)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To determine the onset and offset of antiplatelet effect of AZD6140 compared to clopidogrel by evaluation of the % IPA by LTA and by evaluation of the difference in slope of IPA effect curve by LTA [ Time Frame: Assessed 2 hrs post 1st dose of drug and after the last dose of drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the PK/PD relationship of AZD6140 and its active metabolite; to determine the effect on platelet aggregation of AZD6140 compared to clopidogrel; to assess the overall safety and tolerability of AZD6140 compared to clopidogrel and placebo [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	112
Study Start Date:	October 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Aspirin therapy + Placebo	Drug: aspirin 325 mg oral tablet once daily dose
2: Active Comparator Aspirin + clopidogrel	Drug: Clopidogrel 75 mg once daily oral dosage Drug: aspirin 325 mg oral tablet once daily dose
3: Experimental Aspirin + AZD6140	Drug: AZD6140 oral tablet Drug: aspirin 325 mg oral tablet once daily dose

Eligibility

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

Criteria

Inclusion Criteria:

Documented stable Coronary Artery Disease (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)
History of liver or kidney disease
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: NCT00528411

Locations

United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
Research Site
Towson, Maryland, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, South Dakota
Research Site
Rapid City, South Dakota, United States
United States, Texas
Research Site
Houston, Texas, United States
United Kingdom
Research Site
Sheffield, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Philip Sager, MD	AstraZeneca
Principal Investigator:	Paul Gurbel, MD	Platelet & Thrombosis Research, LLC

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. Epub 2009 Nov 18.

Responsible Party:	AstraZeneca ( Jay Horrow - Medical Science Director )
Study ID Numbers:	D5130C00048
Study First Received:	September 10, 2007
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00528411 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Coronary artery disease
CAD
heart attack
stable angina
Stable coronary artery disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Arteriosclerosis
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Arterial Occlusive Diseases

Heart Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Coronary Disease
Analgesics, Non-Narcotic
Clopidogrel
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010