A Pharmacodynamic Study With Ticagrelor in African American 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

NCT01523392

D5130L00013

Details and patient eligibility

About

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American 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 African American Patients with Stable Coronary Artery Disease

Enrollment: 50 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 African American

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 required dialysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Ticagrelor

Experimental group

Treatment:

Drug: Ticagrelor

Clopidogrel

Active Comparator group

Treatment:

Drug: Clopidogrel