A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

Stable Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523366
• Other study ID #: D5130L00012
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2012
• Last updated: August 14, 2014
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Coronary Artery Disease

Intervention

Drug:
• Ticagrelor
Min - 90mg/Max - 180mg tablets (loading dose)
• Clopidogrel
75mg (once daily)/Max - 600mg tablets (loading dose)

Locations

Country	Name	City	State
United States	Research Site	Hollywood	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Linden	New Jersey
United States	Research Site	Los Angeles	California
United States	Research Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose	Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value	At 2 hours after the loading dose	No
Secondary	Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose	Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value	At 0.5 and 8 hours after the loading dose	No
Secondary	Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8	The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value	At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8	No
Secondary	Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses	The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.	Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose	No
Secondary	AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses	The SD is a statistic using the log-transformed data and is not the geometric SD.	Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose	No

External Links

•   CSR_Synopsis
•   D5130L00012_Clinical_Study_Protocol_Redacted