Trial Outcomes & Findings for Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan (NCT NCT02631057)

Results Overview

The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.

Recruitment status

COMPLETED

Target enrollment

4313 participants

Primary outcome timeframe

From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.

Results posted on

2018-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Dabigatran Etexilate [Prazaxa®] The patients were administered Dabigatran Etexilate 75 mg\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).	Warfarin Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
Overall Study STARTED	899	3414
Overall Study COMPLETED	899	3414
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran Etexilate [Prazaxa®] n=899 Participants The patients were administered Dabigatran Etexilate 75 mg\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).	Warfarin n=3414 Participants Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.	Total n=4313 Participants Total of all reporting groups
Age, Continuous	70.2 Years STANDARD_DEVIATION 11.6 • n=5 Participants	76.1 Years STANDARD_DEVIATION 10.4 • n=7 Participants	74.9 Years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	297 Participants n=5 Participants	1398 Participants n=7 Participants	1695 Participants n=5 Participants
Sex: Female, Male Male	602 Participants n=5 Participants	2016 Participants n=7 Participants	2618 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.

Population: The analysis set included patients who received the treatment Dabigatran Etexilate \[Prazaxa®\] or Warfarin.

The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate [Prazaxa®] n=899 Participants The patients were administered Dabigatran Etexilate 75 mg\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).	Warfarin n=3414 Participants Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline	9.8 Months Standard Deviation 13.5	14.9 Months Standard Deviation 19.4

Adverse Events

Dabigatran Etexilate [Prazaxa®]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warfarin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place