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

Boehringer Ingelheim

Status and phase: Terminated; Phase 2

Conditions: Atrial Fibrillation; Stroke

Treatments: Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00157248

1160.42

Details and patient eligibility

About

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).

Enrollment: 361 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

361 participants in 4 patient groups

dabigatran etexilate, 150 mg once daily

Experimental group

Description:

dosage used at study start

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

dabigatran etexilate, 150 mg twice daily

Experimental group

Description:

dosage used at study start

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

dabigatran etexilate, 300 mg once daily

Experimental group

Description:

dosage used at study start

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

dabigatran etexilate, 300 mg twice daily

Experimental group

Description:

dosage used at study start

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate