Stroke Clinical Trial
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)
NCT number | NCT00157248 |
Other study ID # | 1160.42 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | September 8, 2005 |
Last updated | May 8, 2014 |
Start date | December 2003 |
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).
Status | Terminated |
Enrollment | 361 |
Est. completion date | |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | 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 | 1160.42.45011 Boehringer Ingelheim Investigational Site | Esbjerg | |
Denmark | 1160.42.45012 Boehringer Ingelheim Investigational Site | Frederikssund | |
Denmark | 1160.42.45003 Boehringer Ingelheim Investigational Site | Helsingør | |
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 | |
Netherlands | 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 | |
Sweden | 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 | Malmö | |
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 | |
United States | 1160.42.10015 Boehringer Ingelheim Investigational Site | Baltimore | Maryland |
United States | 1160.42.10014 Boehringer Ingelheim Investigational Site | Hawthorne | New York |
United States | 1160.42.10003 Boehringer Ingelheim Investigational Site | La Mesa | California |
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 | 1160.42.10006 Boehringer Ingelheim Investigational Site | Pensacola | Florida |
United States | 1160.42.10001 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
United States | 1160.42.10012 Boehringer Ingelheim Investigational Site | Pittsfield | Massachusetts |
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 | 1160.42.10007 Boehringer Ingelheim Investigational Site | Troy | Michigan |
United States | 1160.42.10008 Boehringer Ingelheim Investigational Site | Westminster | Maryland |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Denmark, Netherlands, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
Secondary | 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 | 5 years | No |
Secondary | 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 | 5 years | No |
Secondary | 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 | 5 years | Yes |
Secondary | 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 | 5 years | No |
Secondary | 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 |
5 years | No |
Secondary | 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 | 5 years | No |
Secondary | 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 | 5 years | No |
Secondary | 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 | 5 years | No |
Secondary | 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 |
5 years | No |
Secondary | Severe Adverse Event | Frequency of patients with severe adverse events. | 5 years | No |
Secondary | 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] |
5 years | No |
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