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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 ACS patients undergoing an Ad Hoc PCI

Ad Hoc Percutaneous Coronary Intervention study in Acute Coronary Syndrome patients

A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)

Research Site

A randomized, open-label study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome subjects undergoing Ad Hoc percutaneous coronary intervention

Age Categorical

Gender, Male/Female

Race/Ethnicity, Customized

Region of Enrollment

Randomized Analysis Set, defined as all participants who signed informed consent, who provided demographic and/or baseline screening assessments, and who were randomized into the study regardless of the participant's randomization and treatment status in the study.

Participants with low (<150) baseline PRU values were excluded.

Pharmacodynamic (PD) Analysis Set  (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.

Inhibition of the P2Y12 receptor at 2 hours after loading doses of ticagrelor and clopidogrel as measured by P2Y12 Reaction Units (PRU) from VerifyNow™

0.5 hours 

8 hours

End of PCI (n=41 for ticagrelor)

Analysis at 0.5 hours after the loading dose

Analysis at 8 hours after the loading dose.

PD Analysis Set. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses. 

Inhibition of the P2Y12 receptor at 0.5 hours, end of PCI, and 8 hours after loading doses of ticagrelor and clopidogrel as measured by PRU from VerifyNow™

Overall Study

Overall, 343 participants were screened; 102 met inclusion/exclusion criteria, 100 were randomized. 96 participants completed treatment and 97 participants completed the study.

Arms	Assigned Interventions
Experimental: Ticagrelor Ticagrelor - 180 mg loading dose	Drug: Ticagrelor 180 mg loading dose
Active Comparator: Clopidogrel Clopidogrel - 600 mg loading dose	Drug: Clopidogrel 600 mg loading dose

Ad Hoc Percutaneous Coronary Intervention study in Acute Coronary Syndrome 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

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator