Trial Outcomes & Findings for Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation (NCT NCT01546883)

Results Overview

We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

MRI at baseline and MRI at 12 months post-enrollment

Results posted on

2015-10-12

Participant Flow

medical clinic

Participant milestones

Participant milestones
Measure	Dabigatran Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year
Overall Study STARTED	14
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Dabigatran Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	2
Overall Study early closure of study	2
Overall Study other unrelated illness	1

Baseline Characteristics

Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran n=14 Participants Dabigatran
Age, Continuous	60 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: MRI at baseline and MRI at 12 months post-enrollment

Population: Data were not collected for the analysis population and therefore could not be summarized to include in this report.

We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.

Outcome measures

Outcome data not reported

Adverse Events

Dabigatran

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dabigatran n=14 participants at risk Patients taking Dabigatran
Gastrointestinal disorders GI bleed	7.1% 1/14 • Number of events 1

Other adverse events

Other adverse events
Measure	Dabigatran n=14 participants at risk Patients taking Dabigatran
Gastrointestinal disorders abdominal pain	14.3% 2/14 • Number of events 2
Infections and infestations respiratory tract infection	7.1% 1/14 • Number of events 1
Infections and infestations urinary tract infection	7.1% 1/14 • Number of events 1
Gastrointestinal disorders rectal bleeding	7.1% 1/14 • Number of events 1
Gastrointestinal disorders lesions on tongue	7.1% 1/14 • Number of events 1
General disorders shortness of breath, dizziness, fatigue	21.4% 3/14 • Number of events 3

Additional Information

Clinical Research Manager

University of Utah

Phone: 8015873889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60