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

Terminated

Phase 2 Results

Trial Description

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

Interventions

  • Dabigatran etexilate Drug
    Intervention Desc: dosage used at study start
    ARM 1: Kind: Experimental
    Label: dabigatran etexilate, 150 mg once daily
    Description: dosage used at study start
    ARM 2: Kind: Experimental
    Label: dabigatran etexilate, 150 mg twice daily
    Description: dosage used at study start
    ARM 3: Kind: Experimental
    Label: dabigatran etexilate, 300 mg once daily
    Description: dosage used at study start
    ARM 4: Kind: Experimental
    Label: dabigatran etexilate, 300 mg twice daily
    Description: dosage used at study start

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study

Outcomes

Type Measure 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. 7 years No
Primary Yearly Event Rate for Major Bleeding 7 years Yes
Primary Yearly Event Rate for Major + Minor/Relevant Bleeding 7 years Yes
Primary Yearly Event Rate for Any Bleeding 7 years Yes
Secondary Yearly Event Rate for Stroke 7 years No
Secondary Yearly Event Rate of Ischaemic Stroke 7 years No
Secondary Yearly Event Rate of Haemorrhagic Stroke 7 years Yes
Secondary Yearly Event Rate for Transient Ischaemic Attacks 7 years No
Secondary Yearly Event Rate for Systemic Thromboembolism 7 years No
Secondary Yearly Event Rate of Myocardial Infarction 7 years No
Secondary Yearly Event Rate of Other Major Adverse Cardiac Events 7 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 7 years No
Primary Yearly Event Rate for Minor Bleeding 7 years Yes
Secondary Yearly Event Rate of Death 7 years No
Secondary Severe Adverse Event 7 years No
Secondary Laboratory Analyses 7 years No

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