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Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048

Primary Purpose

Atrial Fibrillation, Stroke

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dabigatran etexilate
dabigatran etexilate
dabigatran etexilate
dabigatran etexilate
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Diagnosis and main criteria for inclusion: Paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation with a history of coronary artery disease (CAD) Inclusion Criteria: previous treatment with BIBR 1048 in PETRO (trial 1160.20- NCT01227629) and no premature discontinuation of therapy paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ECG) at least twice prior to enrollment in PETRO concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (DM), congestive heart failure (CHF) or Left ventricular dysfunction (LVD), previous ischemic stroke or transient ischemic attack) TIA, or age greater than 75 years. -age >= 18 years written, informed consent Exclusion criteria Exclusion Criteria: Valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study. contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (GI) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (INR), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than GI hemorrhage). severe renal impairment (estimated glomerular filtration rate [GFR] <= 30 mL/min). uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg and/or diastolic blood pressure [DBP] > 100 mmHg). Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (note: a negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study). Patients who have received an investigational drug other than BIBR 1048 within the last 30 days. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration. Another indication for anticoagulant treatment (eg, deep vein thrombosis or pulmonary embolus). Clinically significant anemia (note: patients with mild-moderate anemia should only be enrolled after the possibility of a GI bleeding source has been evaluated, the etiology of the anemia identified, and appropriate action taken). Patients suffering from thrombocytopenia (platelets < 100,000/uL). Any other condition which, in the discretion of the investigator, would not allow safe participation in the study. Continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (ASA). Recent malignancy or radiation therapy (<= 6 months).

Sites / Locations

  • 1160.42.10003 Boehringer Ingelheim Investigational Site
  • 1160.42.10006 Boehringer Ingelheim Investigational Site
  • 1160.42.10004 Boehringer Ingelheim Investigational Site
  • 1160.42.10002 Boehringer Ingelheim Investigational Site
  • 1160.42.10015 Boehringer Ingelheim Investigational Site
  • 1160.42.10008 Boehringer Ingelheim Investigational Site
  • 1160.42.10012 Boehringer Ingelheim Investigational Site
  • 1160.42.10007 Boehringer Ingelheim Investigational Site
  • 1160.42.10014 Boehringer Ingelheim Investigational Site
  • 1160.42.10013 Boehringer Ingelheim Investigational Site
  • 1160.42.10009 Boehringer Ingelheim Investigational Site
  • 1160.42.10001 Boehringer Ingelheim Investigational Site
  • 1160.42.45010 Boehringer Ingelheim Investigational Site
  • 1160.42.45005 Boehringer Ingelheim Investigational Site
  • 1160.42.45007 Boehringer Ingelheim Investigational Site
  • 1160.42.45011 Boehringer Ingelheim Investigational Site
  • 1160.42.45012 Boehringer Ingelheim Investigational Site
  • 1160.42.45003 Boehringer Ingelheim Investigational Site
  • 1160.42.45004 Boehringer Ingelheim Investigational Site
  • 1160.42.45009 Boehringer Ingelheim Investigational Site
  • 1160.42.45002 Boehringer Ingelheim Investigational Site
  • 1160.42.45014 Boehringer Ingelheim Investigational Site
  • 1160.42.45001 Boehringer Ingelheim Investigational Site
  • 1160.42.45013 Roskilde Sygehus
  • 1160.42.45006 Boehringer Ingelheim Investigational Site
  • 1160.42.31003 Ziekenhuis Amstelveen
  • 1160.42.31001 Academisch Medisch Centrum
  • 1160.42.31013 Onze Lieve Vrouwe Gasthuis
  • 1160.42.31008 Gelre Ziekenhuis, locatie Juliana
  • 1160.42.31006 Wilhelmina Ziekenhuis
  • 1160.42.31007 Gemini Ziekenhuis
  • 1160.42.31002 Ziekenhuis Gelderse Vallei
  • 1160.42.31014 Ziekenhuisgroep Twente
  • 1160.42.31012 Vasculair onderzoekscentrum (VOC)
  • 1160.42.31009 Havenziekenhuis
  • 1160.42.31004 Maasland Ziekenhuis
  • 1160.42.31005 Tweesteden Ziekenhuis
  • 1160.42.31011 Maxima Medisch Centrum
  • 1160.42.46013 Boehringer Ingelheim Investigational Site
  • 1160.42.46007 Boehringer Ingelheim Investigational Site
  • 1160.42.46005 Boehringer Ingelheim Investigational Site
  • 1160.42.46010 Boehringer Ingelheim Investigational Site
  • 1160.42.46009 Boehringer Ingelheim Investigational Site
  • 1160.42.46008 Boehringer Ingelheim Investigational Site
  • 1160.42.46002 Boehringer Ingelheim Investigational Site
  • 1160.42.46011 Boehringer Ingelheim Investigational Site
  • 1160.42.46006 Boehringer Ingelheim Investigational Site
  • 1160.42.46001 Boehringer Ingelheim Investigational Site
  • 1160.42.46003 Boehringer Ingelheim Investigational Site
  • 1160.42.46004 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

dabigatran etexilate, 150 mg once daily

dabigatran etexilate, 150 mg twice daily

dabigatran etexilate, 300 mg once daily

dabigatran etexilate, 300 mg twice daily

Arm Description

dosage used at study start

dosage used at study start

dosage used at study start

dosage used at study start

Outcomes

Primary Outcome Measures

Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.
Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Major Bleeding
Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Major + Minor/Relevant Bleeding
Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Any Bleeding
Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Minor Bleeding
Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds. Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Secondary Outcome Measures

Yearly Event Rate for Stroke
Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate of Ischaemic Stroke
Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate of Haemorrhagic Stroke
Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Transient Ischaemic Attacks
Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Systemic Thromboembolism
Time to first occurrence of any non-central nervous system systemic thromboembolism. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate of Myocardial Infarction
Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate of Other Major Adverse Cardiac Events
Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate of Death
Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality
Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Severe Adverse Event
Frequency of patients with severe adverse events.
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range. Normal ranges are defined as: Alanine aminotransferase (ALT): 5-45 [U/L] Aspartate aminotransferase (AST): 10-40 [U/L] Bilirubin, total: 0.2-1.0 [mg/dL]

Full Information

First Posted
September 8, 2005
Last Updated
May 8, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00157248
Brief Title
Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048
Official Title
Long-term, Open-label Follow-up Treatment of Patients With Atrial Fibrillation Who Have Been Previously Treated With BIBR 1048 in the PETRO Trial (Trial 1160.20 - NCT01227629). (PETRO Extension Trial: PETRO-Ex)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
December 2003 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dabigatran etexilate, 150 mg once daily
Arm Type
Experimental
Arm Description
dosage used at study start
Arm Title
dabigatran etexilate, 150 mg twice daily
Arm Type
Experimental
Arm Description
dosage used at study start
Arm Title
dabigatran etexilate, 300 mg once daily
Arm Type
Experimental
Arm Description
dosage used at study start
Arm Title
dabigatran etexilate, 300 mg twice daily
Arm Type
Experimental
Arm Description
dosage used at study start
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
dosage used at study start
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
dosage used at study start
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
dosage used at study start
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
dosage used at study start
Primary Outcome Measure Information:
Title
Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.
Description
Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate for Major Bleeding
Description
Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate for Major + Minor/Relevant Bleeding
Description
Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate for Any Bleeding
Description
Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate for Minor Bleeding
Description
Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds. Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Yearly Event Rate for Stroke
Description
Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate of Ischaemic Stroke
Description
Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate of Haemorrhagic Stroke
Description
Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate for Transient Ischaemic Attacks
Description
Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate for Systemic Thromboembolism
Description
Time to first occurrence of any non-central nervous system systemic thromboembolism. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate of Myocardial Infarction
Description
Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate of Other Major Adverse Cardiac Events
Description
Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate of Death
Description
Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality
Description
Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Time Frame
5 years
Title
Severe Adverse Event
Description
Frequency of patients with severe adverse events.
Time Frame
5 years
Title
Laboratory Analyses
Description
Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range. Normal ranges are defined as: Alanine aminotransferase (ALT): 5-45 [U/L] Aspartate aminotransferase (AST): 10-40 [U/L] Bilirubin, total: 0.2-1.0 [mg/dL]
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Diagnosis and main criteria for inclusion: Paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation with a history of coronary artery disease (CAD) Inclusion Criteria: previous treatment with BIBR 1048 in PETRO (trial 1160.20- NCT01227629) and no premature discontinuation of therapy paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ECG) at least twice prior to enrollment in PETRO concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (DM), congestive heart failure (CHF) or Left ventricular dysfunction (LVD), previous ischemic stroke or transient ischemic attack) TIA, or age greater than 75 years. -age >= 18 years written, informed consent Exclusion criteria Exclusion Criteria: Valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study. contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (GI) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (INR), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than GI hemorrhage). severe renal impairment (estimated glomerular filtration rate [GFR] <= 30 mL/min). uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg and/or diastolic blood pressure [DBP] > 100 mmHg). Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (note: a negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study). Patients who have received an investigational drug other than BIBR 1048 within the last 30 days. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration. Another indication for anticoagulant treatment (eg, deep vein thrombosis or pulmonary embolus). Clinically significant anemia (note: patients with mild-moderate anemia should only be enrolled after the possibility of a GI bleeding source has been evaluated, the etiology of the anemia identified, and appropriate action taken). Patients suffering from thrombocytopenia (platelets < 100,000/uL). Any other condition which, in the discretion of the investigator, would not allow safe participation in the study. Continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (ASA). Recent malignancy or radiation therapy (<= 6 months).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.42.10003 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
1160.42.10006 Boehringer Ingelheim Investigational Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
1160.42.10004 Boehringer Ingelheim Investigational Site
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
1160.42.10002 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
1160.42.10015 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1160.42.10008 Boehringer Ingelheim Investigational Site
City
Westminster
State/Province
Maryland
Country
United States
Facility Name
1160.42.10012 Boehringer Ingelheim Investigational Site
City
Pittsfield
State/Province
Massachusetts
Country
United States
Facility Name
1160.42.10007 Boehringer Ingelheim Investigational Site
City
Troy
State/Province
Michigan
Country
United States
Facility Name
1160.42.10014 Boehringer Ingelheim Investigational Site
City
Hawthorne
State/Province
New York
Country
United States
Facility Name
1160.42.10013 Boehringer Ingelheim Investigational Site
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
1160.42.10009 Boehringer Ingelheim Investigational Site
City
North Durham
State/Province
North Carolina
Country
United States
Facility Name
1160.42.10001 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1160.42.45010 Boehringer Ingelheim Investigational Site
City
Aalborg
Country
Denmark
Facility Name
1160.42.45005 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1160.42.45007 Boehringer Ingelheim Investigational Site
City
Brædstrup
Country
Denmark
Facility Name
1160.42.45011 Boehringer Ingelheim Investigational Site
City
Esbjerg
Country
Denmark
Facility Name
1160.42.45012 Boehringer Ingelheim Investigational Site
City
Frederikssund
Country
Denmark
Facility Name
1160.42.45003 Boehringer Ingelheim Investigational Site
City
Helsingør
Country
Denmark
Facility Name
1160.42.45004 Boehringer Ingelheim Investigational Site
City
Herlev
Country
Denmark
Facility Name
1160.42.45009 Boehringer Ingelheim Investigational Site
City
Holbæk
Country
Denmark
Facility Name
1160.42.45002 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1160.42.45014 Boehringer Ingelheim Investigational Site
City
Køge
Country
Denmark
Facility Name
1160.42.45001 Boehringer Ingelheim Investigational Site
City
Odense
Country
Denmark
Facility Name
1160.42.45013 Roskilde Sygehus
City
Roskilde
Country
Denmark
Facility Name
1160.42.45006 Boehringer Ingelheim Investigational Site
City
Svendborg
Country
Denmark
Facility Name
1160.42.31003 Ziekenhuis Amstelveen
City
Amstelveen
Country
Netherlands
Facility Name
1160.42.31001 Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
1160.42.31013 Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
1160.42.31008 Gelre Ziekenhuis, locatie Juliana
City
Apeldoorn
Country
Netherlands
Facility Name
1160.42.31006 Wilhelmina Ziekenhuis
City
Assen
Country
Netherlands
Facility Name
1160.42.31007 Gemini Ziekenhuis
City
Den Helder
Country
Netherlands
Facility Name
1160.42.31002 Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
1160.42.31014 Ziekenhuisgroep Twente
City
Hengelo
Country
Netherlands
Facility Name
1160.42.31012 Vasculair onderzoekscentrum (VOC)
City
Hoorn
Country
Netherlands
Facility Name
1160.42.31009 Havenziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
1160.42.31004 Maasland Ziekenhuis
City
Sittard
Country
Netherlands
Facility Name
1160.42.31005 Tweesteden Ziekenhuis
City
Tilburg
Country
Netherlands
Facility Name
1160.42.31011 Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Facility Name
1160.42.46013 Boehringer Ingelheim Investigational Site
City
Eskilstuna
Country
Sweden
Facility Name
1160.42.46007 Boehringer Ingelheim Investigational Site
City
Falun
Country
Sweden
Facility Name
1160.42.46005 Boehringer Ingelheim Investigational Site
City
Jönköping
Country
Sweden
Facility Name
1160.42.46010 Boehringer Ingelheim Investigational Site
City
Kalmar
Country
Sweden
Facility Name
1160.42.46009 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1160.42.46008 Boehringer Ingelheim Investigational Site
City
Norrköping
Country
Sweden
Facility Name
1160.42.46002 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.42.46011 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.42.46006 Boehringer Ingelheim Investigational Site
City
Umeaa
Country
Sweden
Facility Name
1160.42.46001 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1160.42.46003 Boehringer Ingelheim Investigational Site
City
Västerås
Country
Sweden
Facility Name
1160.42.46004 Boehringer Ingelheim Investigational Site
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.42_U09-3247-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.42_literature.pdf
Description
Related Info

Learn more about this trial

Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048

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