A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Stable Coronary Artery Disease

Treatments

Drug: Ticagrelor

Drug: Clopidogrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01523366

D5130L00012

Details and patient eligibility

About

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

Full 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

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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