Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048
NCT ID: NCT00157248
Last Updated: 2014-05-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
361 participants
INTERVENTIONAL
2003-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
NCT01136408
Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
NCT02833948
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
NCT01734772
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
NCT02991118
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
NCT01776424
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
dabigatran etexilate, 150 mg once daily
dosage used at study start
dabigatran etexilate
dosage used at study start
dabigatran etexilate, 150 mg twice daily
dosage used at study start
dabigatran etexilate
dosage used at study start
dabigatran etexilate, 300 mg once daily
dosage used at study start
dabigatran etexilate
dosage used at study start
dabigatran etexilate, 300 mg twice daily
dosage used at study start
dabigatran etexilate
dosage used at study start
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dabigatran etexilate
dosage used at study start
dabigatran etexilate
dosage used at study start
dabigatran etexilate
dosage used at study start
dabigatran etexilate
dosage used at study start
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Boehringer Ingelheim
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1160.42.10003 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1160.42.10006 Boehringer Ingelheim Investigational Site
Pensacola, Florida, United States
1160.42.10004 Boehringer Ingelheim Investigational Site
Port Charlotte, Florida, United States
1160.42.10002 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
1160.42.10015 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1160.42.10008 Boehringer Ingelheim Investigational Site
Westminster, Maryland, United States
1160.42.10012 Boehringer Ingelheim Investigational Site
Pittsfield, Massachusetts, United States
1160.42.10007 Boehringer Ingelheim Investigational Site
Troy, Michigan, United States
1160.42.10014 Boehringer Ingelheim Investigational Site
Hawthorne, New York, United States
1160.42.10013 Boehringer Ingelheim Investigational Site
New Hyde Park, New York, United States
1160.42.10009 Boehringer Ingelheim Investigational Site
North Durham, North Carolina, United States
1160.42.10001 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1160.42.45010 Boehringer Ingelheim Investigational Site
Aalborg, , Denmark
1160.42.45005 Boehringer Ingelheim Investigational Site
Aarhus C, , Denmark
1160.42.45007 Boehringer Ingelheim Investigational Site
Brædstrup, , Denmark
1160.42.45003 Boehringer Ingelheim Investigational Site
Elsinore, , Denmark
1160.42.45011 Boehringer Ingelheim Investigational Site
Esbjerg, , Denmark
1160.42.45012 Boehringer Ingelheim Investigational Site
Frederikssund, , Denmark
1160.42.45004 Boehringer Ingelheim Investigational Site
Herlev, , Denmark
1160.42.45009 Boehringer Ingelheim Investigational Site
Holbæk, , Denmark
1160.42.45002 Boehringer Ingelheim Investigational Site
Hvidovre, , Denmark
1160.42.45014 Boehringer Ingelheim Investigational Site
Køge, , Denmark
1160.42.45001 Boehringer Ingelheim Investigational Site
Odense, , Denmark
1160.42.45013 Roskilde Sygehus
Roskilde, , Denmark
1160.42.45006 Boehringer Ingelheim Investigational Site
Svendborg, , Denmark
1160.42.31003 Ziekenhuis Amstelveen
Amstelveen, , Netherlands
1160.42.31001 Academisch Medisch Centrum
Amsterdam, , Netherlands
1160.42.31013 Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
1160.42.31008 Gelre Ziekenhuis, locatie Juliana
Apeldoorn, , Netherlands
1160.42.31006 Wilhelmina Ziekenhuis
Assen, , Netherlands
1160.42.31007 Gemini Ziekenhuis
Den Helder, , Netherlands
1160.42.31002 Ziekenhuis Gelderse Vallei
Ede, , Netherlands
1160.42.31014 Ziekenhuisgroep Twente
Hengelo, , Netherlands
1160.42.31012 Vasculair onderzoekscentrum (VOC)
Hoorn, , Netherlands
1160.42.31009 Havenziekenhuis
Rotterdam, , Netherlands
1160.42.31004 Maasland Ziekenhuis
Sittard, , Netherlands
1160.42.31005 Tweesteden Ziekenhuis
Tilburg, , Netherlands
1160.42.31011 Maxima Medisch Centrum
Veldhoven, , Netherlands
1160.42.46013 Boehringer Ingelheim Investigational Site
Eskilstuna, , Sweden
1160.42.46007 Boehringer Ingelheim Investigational Site
Falun, , Sweden
1160.42.46005 Boehringer Ingelheim Investigational Site
Jönköping, , Sweden
1160.42.46010 Boehringer Ingelheim Investigational Site
Kalmar, , Sweden
1160.42.46009 Boehringer Ingelheim Investigational Site
Malmo, , Sweden
1160.42.46008 Boehringer Ingelheim Investigational Site
Norrköping, , Sweden
1160.42.46004 Boehringer Ingelheim Investigational Site
Örebro, , Sweden
1160.42.46002 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
1160.42.46011 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
1160.42.46006 Boehringer Ingelheim Investigational Site
Umeaa, , Sweden
1160.42.46001 Boehringer Ingelheim Investigational Site
Uppsala, , Sweden
1160.42.46003 Boehringer Ingelheim Investigational Site
Västerås, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1160.42
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.