check_circleStudy Completed

atrial fibrillation

Bayer Identifier:

16677

ClinicalTrials.gov Identifier:

NCT01928979

EudraCT Number:

Not Available

EU CT Number:

Not Available
Retrospective registry providing baseline data on the outcome of left atrial (LA) or LA appendage (LAA) thrombus in patients with nonvalvular atrial fibrillation (AF) or atrial flutter after standard of care (SoC) anticoagulant therapy

Trial purpose

Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with nonvalvular AF or atrial flutter documented with LA/ LAA thrombi on transesophag-eal echocardiography (TEE).
The study is a company-sponsored, global, multi-center, retrospective, non-interventional study. Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012 will be identified through screening and review of medical records and included in the registry. Retrospective patient data will be collected from May 2nd, 2013 to May 2nd, 2014. The observation of each patient will cover the period from the diagnosis of an LA/ LAA thrombus until the end-of-treatment TEE following the 3-12 week SoC anticoagulation (AC) therapy. If no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy, the observational period will end at 12 weeks after diagnosis at the latest. If more than one TEE was performed during treatment, the thrombus outcome will be collected from the last TEE performed within 12 weeks of treatment start.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Men or women age ≥ 18 years at data recording
    - Hemodynamically stable nonvalvular AF or atrial flutter
    - Documented LA/ LA thrombus on TEE
  • - Valvular AF ( ESC 2012 definition)
    - History of cardiac thrombus confirmed on TEE
    - Intracardiac tumors, e.g. atrial myxoma
    - Active endocarditis

Trial summary

Enrollment Goal
160
Trial Dates
May 2013 - December 2014
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medizinische Einrichtungen der Universität BonnMany Locations, 53105, Germany
Completed
Hopital Saint Antoine - ParisMany Locations, 75012, France
Completed
Wojewodzki Specjalistyczny Szpital im. dr Wl. BieganskiegoMany Locations, 91-347, Poland
Completed
MHAT National Cardiology Hospital EADMany Locations, 1309, Bulgaria
Completed
Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitMany Locations, 34846, Turkey
Completed
Municipal Hospital N 4Many Locations, 115093, Russia
Completed
Regional Clinical HospitalMany Locations, 65025, Ukraine

Primary Outcome

  • Thrombus resolution (completely disappeared) rate confirmed on TEE.
    date_rangeTime Frame:
    after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Stroke or non central nervous system (CNS) systemic thromboembolism rate
    date_rangeTime Frame:
    after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
    enhanced_encryption
    Safety Issue:
    No
  • All bleeding (major, non-major, unknown severity) rates
    date_rangeTime Frame:
    after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Retrospective registry providing baseline data on the outcome of left atrial (LA) or LA appendage (LAA) thrombus in patients with nonvalvular atrial fibrillation (AF) or atrial flutter after standard of care (SoC) anticoagulant therapy
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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