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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

A pharmacodynamic study with ticagrelor in African American patients

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

Min - 90mg/Max - 180mg tablets (loading dose)

75mg (once daily)/Max - 600mg tablets (loading dose)

Research Site

Age, Customized

Gender, Male/Female

Race/Ethnicity, Customized

Region of Enrollment

Randomized Analysis Set for demography (N=34) - included all patients who signed informed consent and were randomized into the study. 

Pharmacodynamic (PD) Analysis Set (N=32) - included all participants for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel

Inhibition of the P2Y12 receptor as measured by Platelet Reaction Unit (PRU) from VerifyNow™ (a platelet function test developed by Accumetrics) at 2 hours after loading dose

0.5 hours

8 hours (N=28 ticagrelor, N=27 clopidogrel)

Inhibition of the P2Y12 receptor as measured by PRU from VerifyNow™ at 0.5 hour and 8 hours after loading dose

2 hours on Day 7 (N=27 for clopidogrel)

8 hours on Day 7 

End of dosing interval on Day 8

Analysis at 2 hours on Day 7 after multiple doses

Analysis at 8 hours on Day 7 after multiple doses

Analysis at end of dosing interval on Day 8

Inhibition of the P2Y12 receptor as measured by PRU from VerifyNow™ at 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8

Baseline (0 pre-dose hours)

0.5 hours after the loading dose

2 hours after the loading dose

8 hours after the loading dose - Period 1 N=19

0 hours after multiple doses - Period 1 N=18

2 hours after multiple doses - Period 1 N=18

8 hours after multiple doses - Period 1 N=18

End of dosing interval on Day 8 - Period 1 N=18

The standard deviation (SD) is the geometric SD

Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available

Ticagrelor plasma concentrations after the loading and maintenance doses

AR-C124910XX (an active metabolite of Ticagrelor) plasma concentrations after the loading and maintenance doses

Treatment Period 1

Washout Period - 10 to 14 days

Treatment Period 2

50 patients screened; 34 patients randomized; 30 patients completed the study (7, 8, or 9 days of both treatments), and 31 completed follow-up

Arms	Assigned Interventions
Experimental: Ticagrelor	Drug: Ticagrelor Min - 90mg/Max - 180mg tablets (loading dose)
Active Comparator: Clopidogrel	Drug: Clopidogrel 75mg (once daily)/Max - 600mg tablets (loading dose)

A pharmacodynamic study with ticagrelor in African American patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D5130L00013_Study_Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator