A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin

Completed · Phase 2

Conditions studied: Coronary Artery Disease

In brief

The purpose of this study is to see how Ticagrelor, 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 investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.

Key facts

Study ID

NCT00528411

Run by

AstraZeneca

People needed

123

Starts

2007-10-01

Expected to finish

2009-03-01

Last updated by the study team

2012-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or Coronary Artery Bypass Graft (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

Where it is running

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

Full record on ClinicalTrials.gov

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