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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 safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.

Atrial Fibrillation (AF) patients not taking Vitamin-K Antagonist (VKA)

Research Site

A controlled, randomized, parallel , multi-centre feasibility study of the oral direct thrombin inhibitor, AZD0837, given as ER formulation, in the prevention of stroke and systolic embolic events in patients with atrial fibrillation, who are appropriate for but unable/unwilling to take VKA therapy

The premature discontinuation of study or study drug due to any reason

The premature discontinuation of study drug due to any reason

|The premature discontinuation of study due to any reason

[(number of doses dispensed-number of doses returned)/number of days between visits]*100

(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100

Age Continuous

Gender, Male/Female

Premature discontinuation of study or study drug due to any reason

Premature discontinuation of study drug due to any reason

Premature discontinuation of study due to any reason

Compliance with study drug

Compliance with study visits/assessments

Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once

41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However,  one of the participants randomized to arm 2 was treated according to treatment arm 3

Bleeding events

Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

Change in Creatinine level

Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.

Alanine aminotransferase (ALAT)

Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.

Bilirubin

Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit

Plasma concentration of AZD0837 (prodrug)

Assessment of plasma concentration of AR-H067637XX (active metabolite)  made on the week 4 visit 

Plasma concentration of AR-H067637XX (active  metabolite)

Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for  patients while on study drug (week 4 visit-baseline)

Change in D-Dimer level

Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

Activated partial thromboplastin time (APTT)

Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

Ecarin clotting time (ECT)

Overall Study

For participants treated with Vitamin K Antagonists (VKA) at the time of enrollment, VKA treatment was to be adjusted (and stopped before randomisation) to ensure that INR was below 2.0 at randomisation. If this was not achieved the participant was discontinued from the study.

Gerard Lynch

Assessment of plasma concentration of AR-H067637XX (active metabolite)  made on the week 4 visit

Atrial Fibrillation (AF) patients not taking Vitamin-K Antagonist (VKA)

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

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=255&filename=CSR-D1250C00051.pdf

CSR-D1250C00051.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator