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

NCT00157248 | Terminated Phase 2 Results

• 1 other identifier: 1160.42
• Study Type: interventional
• Target: 361
• Locations: 4 countries
• Sites: 50

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).

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (5)

• 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

  5 years

• 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

  5 years

• 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

  5 years

• 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

  5 years

• 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

  5 years

Secondary Outcomes (11)

• Yearly Event Rate for Stroke

  5 years

• Yearly Event Rate of Ischaemic Stroke

  5 years

• Yearly Event Rate of Haemorrhagic Stroke

  5 years

• Yearly Event Rate for Transient Ischaemic Attacks

  5 years

• Yearly Event Rate for Systemic Thromboembolism

  5 years

Study Arms (4)

dabigatran etexilate, 150 mg once daily

EXPERIMENTAL

dosage used at study start

Drug: dabigatran etexilate

dabigatran etexilate, 150 mg twice daily

EXPERIMENTAL

dosage used at study start

Drug: dabigatran etexilate

dabigatran etexilate, 300 mg once daily

EXPERIMENTAL

dosage used at study start

Drug: dabigatran etexilate

dabigatran etexilate, 300 mg twice daily

EXPERIMENTAL

dosage used at study start

Drug: dabigatran etexilate

Interventions

dabigatran etexilate DRUG

dosage used at study start

dabigatran etexilate, 150 mg once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (50)

1160.42.10003 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

Location

1160.42.10006 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Location

1160.42.10004 Boehringer Ingelheim Investigational Site

Port Charlotte, Florida, United States

Location

1160.42.10002 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

1160.42.10015 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1160.42.10008 Boehringer Ingelheim Investigational Site

Westminster, Maryland, United States

Location

1160.42.10012 Boehringer Ingelheim Investigational Site

Pittsfield, Massachusetts, United States

Location

1160.42.10007 Boehringer Ingelheim Investigational Site

Troy, Michigan, United States

Location

1160.42.10014 Boehringer Ingelheim Investigational Site

Hawthorne, New York, United States

Location

1160.42.10013 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

Location

1160.42.10009 Boehringer Ingelheim Investigational Site

North Durham, North Carolina, United States

Location

1160.42.10001 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1160.42.45010 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

1160.42.45005 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1160.42.45007 Boehringer Ingelheim Investigational Site

Brædstrup, Denmark

Location

1160.42.45003 Boehringer Ingelheim Investigational Site

Elsinore, Denmark

Location

1160.42.45011 Boehringer Ingelheim Investigational Site

Esbjerg, Denmark

Location

1160.42.45012 Boehringer Ingelheim Investigational Site

Frederikssund, Denmark

Location

1160.42.45004 Boehringer Ingelheim Investigational Site

Herlev, Denmark

Location

1160.42.45009 Boehringer Ingelheim Investigational Site

Holbæk, Denmark

Location

1160.42.45002 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1160.42.45014 Boehringer Ingelheim Investigational Site

Køge, Denmark

Location

1160.42.45001 Boehringer Ingelheim Investigational Site

Odense, Denmark

Location

1160.42.45013 Roskilde Sygehus

Roskilde, Denmark

Location

1160.42.45006 Boehringer Ingelheim Investigational Site

Svendborg, Denmark

Location

1160.42.31003 Ziekenhuis Amstelveen

Amstelveen, Netherlands

Location

1160.42.31001 Academisch Medisch Centrum

Amsterdam, Netherlands

Location

1160.42.31013 Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

1160.42.31008 Gelre Ziekenhuis, locatie Juliana

Apeldoorn, Netherlands

Location

1160.42.31006 Wilhelmina Ziekenhuis

Assen, Netherlands

Location

1160.42.31007 Gemini Ziekenhuis

Den Helder, Netherlands

Location

1160.42.31002 Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

1160.42.31014 Ziekenhuisgroep Twente

Hengelo, Netherlands

Location

1160.42.31012 Vasculair onderzoekscentrum (VOC)

Hoorn, Netherlands

Location

1160.42.31009 Havenziekenhuis

Rotterdam, Netherlands

Location

1160.42.31004 Maasland Ziekenhuis

Sittard, Netherlands

Location

1160.42.31005 Tweesteden Ziekenhuis

Tilburg, Netherlands

Location

1160.42.31011 Maxima Medisch Centrum

Veldhoven, Netherlands

Location

1160.42.46013 Boehringer Ingelheim Investigational Site

Eskilstuna, Sweden

Location

1160.42.46007 Boehringer Ingelheim Investigational Site

Falun, Sweden

Location

1160.42.46005 Boehringer Ingelheim Investigational Site

Jönköping, Sweden

Location

1160.42.46010 Boehringer Ingelheim Investigational Site

Kalmar, Sweden

Location

1160.42.46009 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1160.42.46008 Boehringer Ingelheim Investigational Site

Norrköping, Sweden

Location

1160.42.46004 Boehringer Ingelheim Investigational Site

Örebro, Sweden

Location

1160.42.46002 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.42.46011 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.42.46006 Boehringer Ingelheim Investigational Site

Umeaa, Sweden

Location

1160.42.46001 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1160.42.46003 Boehringer Ingelheim Investigational Site

Västerås, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2003
• Primary Completion: January 1, 2009
• Last Updated: May 19, 2014
• Results First Posted: February 3, 2011

Record last verified: 2014-02

Locations

DK (13); US (12); NL (13); SE (12)