Overview

A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
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 the effect of Ticagrelor on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Aspirin
Clopidogrel
Ticagrelor
Ticlopidine
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 coronary artery bypass graft (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