Clinical trial NCT00157248: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: PREVENTION

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).


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).

Primary outcomes:
measure: Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.
timeFrame: 5 years
measure: Yearly Event Rate for Major Bleeding
timeFrame: 5 years
measure: Yearly Event Rate for Major + Minor/Relevant Bleeding
timeFrame: 5 years
measure: Yearly Event Rate for Any Bleeding
timeFrame: 5 years
measure: Yearly Event Rate for Minor Bleeding
timeFrame: 5 years
Secondary outcomes:
measure: Yearly Event Rate for Stroke
timeFrame: 5 years
measure: Yearly Event Rate of Ischaemic Stroke
timeFrame: 5 years
measure: Yearly Event Rate of Haemorrhagic Stroke
timeFrame: 5 years
measure: Yearly Event Rate for Transient Ischaemic Attacks
timeFrame: 5 years
measure: Yearly Event Rate for Systemic Thromboembolism
timeFrame: 5 years
measure: Yearly Event Rate of Myocardial Infarction
timeFrame: 5 years
measure: Yearly Event Rate of Other Major Adverse Cardiac Events
timeFrame: 5 years
measure: Yearly Event Rate of Death
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Severe Adverse Event
timeFrame: 5 years
measure: Laboratory Analyses
timeFrame: 5 years
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: 1160.42.10003 Boehringer Ingelheim Investigational Site
state: California
city: Pensacola
country: United States
facility: 1160.42.10006 Boehringer Ingelheim Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: 1160.42.10004 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 1160.42.10002 Boehringer Ingelheim Investigational Site
state: Florida
city: Baltimore
country: United States
facility: 1160.42.10015 Boehringer Ingelheim Investigational Site
state: Maryland
city: Westminster
country: United States
facility: 1160.42.10008 Boehringer Ingelheim Investigational Site
state: Maryland
city: Pittsfield
country: United States
facility: 1160.42.10012 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Troy
country: United States
facility: 1160.42.10007 Boehringer Ingelheim Investigational Site
state: Michigan
city: Hawthorne
country: United States
facility: 1160.42.10014 Boehringer Ingelheim Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: 1160.42.10013 Boehringer Ingelheim Investigational Site
state: New York
city: North Durham
country: United States
facility: 1160.42.10009 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: 1160.42.10001 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Aalborg
country: Denmark
facility: 1160.42.45010 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1160.42.45005 Boehringer Ingelheim Investigational Site
city: Brædstrup
country: Denmark
facility: 1160.42.45007 Boehringer Ingelheim Investigational Site
city: Esbjerg
country: Denmark
facility: 1160.42.45011 Boehringer Ingelheim Investigational Site
city: Frederikssund
country: Denmark
facility: 1160.42.45012 Boehringer Ingelheim Investigational Site
city: Helsingør
country: Denmark
facility: 1160.42.45003 Boehringer Ingelheim Investigational Site
city: Herlev
country: Denmark
facility: 1160.42.45004 Boehringer Ingelheim Investigational Site
city: Holbæk
country: Denmark
facility: 1160.42.45009 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1160.42.45002 Boehringer Ingelheim Investigational Site
city: Køge
country: Denmark
facility: 1160.42.45014 Boehringer Ingelheim Investigational Site
city: Odense
country: Denmark
facility: 1160.42.45001 Boehringer Ingelheim Investigational Site
city: Roskilde
country: Denmark
facility: 1160.42.45013 Roskilde Sygehus
city: Svendborg
country: Denmark
facility: 1160.42.45006 Boehringer Ingelheim Investigational Site
city: Amstelveen
country: Netherlands
facility: 1160.42.31003 Ziekenhuis Amstelveen
city: Amsterdam
country: Netherlands
facility: 1160.42.31001 Academisch Medisch Centrum
city: Amsterdam
country: Netherlands
facility: 1160.42.31013 Onze Lieve Vrouwe Gasthuis
city: Apeldoorn
country: Netherlands
facility: 1160.42.31008 Gelre Ziekenhuis, locatie Juliana
city: Assen
country: Netherlands
facility: 1160.42.31006 Wilhelmina Ziekenhuis
city: Den Helder
country: Netherlands
facility: 1160.42.31007 Gemini Ziekenhuis
city: Ede
country: Netherlands
facility: 1160.42.31002 Ziekenhuis Gelderse Vallei
city: Hengelo
country: Netherlands
facility: 1160.42.31014 Ziekenhuisgroep Twente
city: Hoorn
country: Netherlands
facility: 1160.42.31012 Vasculair onderzoekscentrum (VOC)
city: Rotterdam
country: Netherlands
facility: 1160.42.31009 Havenziekenhuis
city: Sittard
country: Netherlands
facility: 1160.42.31004 Maasland Ziekenhuis
city: Tilburg
country: Netherlands
facility: 1160.42.31005 Tweesteden Ziekenhuis
city: Veldhoven
country: Netherlands
facility: 1160.42.31011 Maxima Medisch Centrum
city: Eskilstuna
country: Sweden
facility: 1160.42.46013 Boehringer Ingelheim Investigational Site
city: Falun
country: Sweden
facility: 1160.42.46007 Boehringer Ingelheim Investigational Site
city: Jönköping
country: Sweden
facility: 1160.42.46005 Boehringer Ingelheim Investigational Site
city: Kalmar
country: Sweden
facility: 1160.42.46010 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1160.42.46009 Boehringer Ingelheim Investigational Site
city: Norrköping
country: Sweden
facility: 1160.42.46008 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.42.46002 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.42.46011 Boehringer Ingelheim Investigational Site
city: Umeaa
country: Sweden
facility: 1160.42.46006 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1160.42.46001 Boehringer Ingelheim Investigational Site
city: Västerås
country: Sweden
facility: 1160.42.46003 Boehringer Ingelheim Investigational Site
city: Örebro
country: Sweden
facility: 1160.42.46004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: