Status:

COMPLETED

A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

Lead Sponsor:

AstraZeneca

Conditions:

Stable Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

Detailed Description

A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease

Eligibility Criteria

Inclusion

  • Provision of signed and dated informed consent before initiation of any study-related procedures
  • Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
  • Females must be post menopausal or surgically sterile Self-identified as Hispanic

Exclusion

  • Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
  • Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
  • Current smokers, including the use of tobacco containing products in the past 1 month of randomization
  • Patients requiring dialysis

Key Trial Info

Start Date :

April 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2013

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT01523366

Start Date

April 1 2012

End Date

May 1 2013

Last Update

August 18 2014

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Research Site

Los Angeles, California, United States

2

Research Site

Hollywood, Florida, United States

3

Research Site

Jacksonville, Florida, United States

4

Research Site

Miami, Florida, United States