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

Stopped early · Phase 2

Conditions studied: Atrial Fibrillation, Stroke

In brief

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).

Key facts

Study ID

NCT00157248

Run by

Boehringer Ingelheim

People needed

361

Starts

2003-12-01

Last updated by the study team

2014-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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