UMIN-CTR Clinical Trial

Public title

Investigation of the incidence, severity, and treatment of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation (NVAF)

Acronym

Dabigatran Dyspepsia Dialogue

Scientific Title

Investigation of the incidence, severity, and treatment of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation (NVAF)

Scientific Title:Acronym

Dabigatran Dyspepsia Dialogue

Region

Japan

Condition

Non-valvular atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Part 1: To investigate the incidence and severity of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation using a prospective observational design.
Part 2: To investigate the therapeutic effect and safety of proton pump inhibitors, H2 receptor antagonists, and gastric mucosal protective drugs using an open-label, randomized, parallel-group, comparative design, in patients who have experienced dyspepsia symptoms with GOS (Global Overall Severity) scale score of 3 or higher during the observational phase of the study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

- Severity of dyspepsia symptoms during the observational phase of the study
- Improvement rate of dyspepsia symptoms

Key secondary outcomes

- Percentage of patients with improvement in the severity of dyspepsia symptoms by two points or more on the GOS scale
- Percentage of patients with resolution of dyspepsia symptoms (i.e., percentage of patients with improvement in the severity to a GOS scale score of 1)
- Percentage of patients with improvement in dyspepsia symptoms (i.e., percentage of patients who still have their main dyspepsia symptoms, but with improvement in the severity to a GOS scale score of 1 or 2)
- Post-treatment severity of dyspepsia symptoms compared with baseline (i.e., change in the GOS scale score from baseline)
- Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of a proton pump inhibitor

Interventions/Control_2

Administration of an H2 receptor antagonists

Interventions/Control_3

Administration of a gastric mucosal protective drug

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria for Part 1
Patients who meet all of the following criteria will be included in Part 1 of the study:
1. Have non-valvular atrial fibrillation (paroxysmal, persistent, or permanent) (inpatients or outpatients)
2. Planned to be started on dabigatran therapy for prevention of ischemic stroke and systemic embolism associated with non-valvular atrial fibrillation
3. Do not have any dyspepsia symptoms (dyspepsia, upper abdominal pain, abdominal pain, abdominal discomfort, or epigastric discomfort)
4. Aged 20 years or older at the time of consent
5. Capable of providing written consent in person to participate in the study

Inclusion criteria for Part 2
Participants of Part 1 who meet all of the following criteria will proceed to Part 2 of the study:
1. Receiving dabigatran for prevention of ischemic stroke and systemic embolism associated with non-valvular atrial fibrillation
2. Have experienced dyspepsia symptoms (dyspepsia, upper abdominal pain, abdominal pain, abdominal discomfort, and/or epigastric discomfort) with GOS (Global Overall Severity) scale score of 3 or higher during Part 1 of the study

Key exclusion criteria

Patients who meet any of the following criteria will be excluded from the study:
1. Have a history of hypersensitivity to any ingredients of the dabigatran preparation
2. Undergoing dialysis or have severe renal disorder (creatinine clearance < 30 mL/min*1)
3. Have hemorrhagic symptoms, hemorrhagic diathesis, or hemostatic disturbance
4. Have any organic lesion posing a clinically significant risk for bleeding (including onset of hemorrhagic stroke within the past 6 months)
5. Have a spinal/epidural catheter in place
6. Receiving (oral) itraconazole
7. Have undergone surgery for upper gastrointestinal tract (e.g., esophageal, gastric) resection or vagotomy
8. Have any organic disease confirmed by upper gastrointestinal endoscopy or X-ray performed within one year prior to the consent
9. Women with established or possible pregnancy, nursing mothers, or women who desire to become pregnant during the study participation
10. Other patients judged by the attending physician to be inappropriate as subjects

Patients who meet any of the following criteria will be excluded from Part 2 of the study:
1. Receiving proton pump inhibitors, H2 receptor antagonists, or rebamipide (Mucosta)
2. Have a history of hypersensitivity to any ingredients of the study drug for dyspepsia symptoms, thus precluding administration of the study treatment
3. Have severe renal disorder (creatinine clearance < 30 mL/min*1)
4. Have dyspepsia symptoms that are apparently due to causative factors other than dabigatran, such as overdrinking, overeating, abrupt stress, or concomitant medication
5. Have experienced upper gastrointestinal bleeding or gastric/duodenal ulcerative disease during Part 1 of the study
6. Have concurrent gastroesophageal reflux disease confirmed by endoscopy or X-ray performed during Part 1 of the study
7. Other patients judged by the attending physician to be inappropriate as subjects

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Takeshi Yamashita

Organization

Cardiovascular Institute Hospital

Division name

Director

Zip code

Address

3-2-19 Nishiazabu, Minato-Ku, Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

3D -Study Secretariat

Division name

Research Promotion Group, Mebix Inc.

Zip code

Address

1-11-44 Akasaka, Minato-ku, Tokyo

TEL

03-6229-8936

Homepage URL

Email

dabi-dyspepsia@mebix.co.jp

Institute

Committee on Proper Use of Anticoagulant Therapies

Institute

Department

Personal name

Organization

The Waksman Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

03

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

01

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

03

Month

27

Day

Last modified on

2015

Year

05

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008948