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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 Hispanic patients with stable coronary artery disease.

A pharmacodynamic study with ticagrelor in Hispanic patients

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

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

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

D5130L00012_Clinical_Study_Protocol_Redacted

Research Site

Age, Customized

Gender, Male/Female

Region of Enrollment

Race/Ethnicity, Customized

Randomized Analysis Set for demography (N=40) - included all patients who signed informed consent and were randomized into the study. Pharmacodynamic (PD) Analysis Set for outcomes (N=38) - included all patients for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel

Total N for the secondary outcome analysis after multiple doses and for PK measures was not the same for 2 hours, 8 hours and end of dosing. Only the first time point total N can be reported via the form. Row titles indicate N's where they differ.

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

Inhibition of the P2Y12 receptor as measured by PRU from VerifyNow™ at 2 hours after loading dose

0.5 hours

8 hours

Analysis at 0.5 hours after the loading dose

Analysis at 8 hours after the loading dose

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

2 hours on day 7

8 hours on Day 7 -ticagrelor N=36 clopidogrel N=33

End of Dosing Interval on Day 8 - N's per 8 hours

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

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 and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8

Baseline (0 hours - pre-dose)

0,.5 hours after the loading dose

2 hours after the loading dose - Period 2 N=18

8 hours after the loading dose

0 hours after multiple doses

2 hours after multiple doses

8 hours after multiple doses

End of dosing interval on Day 8 - Period 1 N=17

The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.

Pharmacokinetic (PK) Analysis Set, defined as all participants for whom at least one valid PK reading was available

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.

AR-C124910XX plasma concentrations after the loading and maintenance doses

Treatment Period 1

Washout Period - 10-14 days

Treatment Period 2

53 patients screened; 40 patients randomized; 38 patients completed the study (7, 8, or 9 days of both treatment sequences), and 39 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 Hispanic 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

CSR Synopsis

D5130L00012_Clinical_Study_Protocol_Redacted

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator