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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

A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome

Brilinta DaYu Study

NCT ID

Therapeutic Area

D5130C00087 Clinical Study Protocol and amendment redacted

Research Site

A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome(ACS)

PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal

SAEs except the blending events which have aleady been reported as SAEs.

Age Continuous

Age, Customized

Gender, Male/Female

Race/Ethnicity, Customized

Based on the safety population, i.e. all enrolled patients who received at least one dose of Investigational product (IP)

Fatal/life threatening

Major

Major + minor

Major + minor + minimal

Bleeding events 

SAEs except the blending events which have aleady been reported as SAEs. 

Brilinta DaYu Study - DaYu

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

D5130C00087 Clinical Study Protocol and amendment redacted

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator