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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01523366
Other study ID # D5130L00012
Secondary ID
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


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
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