A Study of the Onset and Offset of Antiplatelet Effects Comparing AZD6140, Clopidogrel, and Placebo With Aspirin
|
Status:
Ongoing. This study is currently recruiting participants.
Purpose:
The purpose of this study is to see how AZD6140, a new oral reversible anti-platelet medication, affects platelets. 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.
Interventions:
Aspirin
Antiplatelet agent; inhibits thromboxane A2; antipyretic
|
AZD6140
AZD6140 is being studied as the first reversible oral adenosine diphosphate (ADP) receptor antagonist for acute coronary syndromes (ACS). It is proposed to selectively inhibit the P2Y12 receptor, a key target receptor for ADP on platelets.
|
Clopidogrel
Antiplatelet agent
|
Year Started:
2007
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study.
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; increased bleeding risk, eg, recent gastrointestinal hemorrhage, uncontrolled high blood pressure, low platelet count, recent major trauma; history of intolerance or allergy to aspirin or clopidogrel.
Patient Involvement:
Patients will be randomized to one of 3 arms: Active Comparator arm (1) will get Aspirin 325 mg + Placebo; Active Comparator arm (2) will get Aspirin 325 mg + clopidogrel 75 mg ; and Experimental arm (3) Aspirin 325 mg + AZD6140 . All given once daily. Primary outcome is assessed 2 hours after first and last doses. Secondary outcomes are assessed at each visit.
Primary Outcome:
To determine the onset and offset of antiplatelet effect of AZD6140 compared to clopidogrel by evaluation of the percentage of inhibition of platelet aggregation by light transmission aggregometry (LTA) and by evaluation of the difference in slope of inhibition of platelet aggregation effect curve by LTA.
Secondary Outcome:
To evaluate the pharmacokinetic/pharmacodynamic 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.
Source of Information:
ClinicalTrials.gov
|
|
Web Links and Publications:
|
|
This information last updated on: 9/22/2008
Reviewed on: 06/19/2009.
|
Trials
Directories