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

Atrial Fibrillation Clinical Trial

— CLOT-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928979
• Other study ID #: 16677
• Secondary ID: NN1301
• Status: Completed
• Phase: N/A
• First received: August 22, 2013
• Last updated: December 21, 2014
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyBulgaria: Ethics committeeBulgaria: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des MédecinsFrance: Direction Générale de la SantéFrance: French Data Protection AuthorityFrance: Haute Autorité de Santé Transparency CommissionFrance: Institutional Ethical CommitteeFrance: Ministry of HealthFrance: National Consultative Ethics Committee for Health and Life SciencesFrance: The Commission nationale de l’informatique et des libertésGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Education and ResearchGermany: Federal Ministry of Food, Agriculture and Consumer ProtectionGermany: Federal Office for Radiation ProtectionGermany: German Institute of Medical Documentation and InformationGermany: Ministry of HealthGermany: Ministry of Work, Health and Social Affairs in North Rhine-WestphGermany: Paul-Ehrlich-InstitutGermany: The Bavarian State Ministry of the Environment and Public HealthPoland: Ethics CommitteePoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: National Institute of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: The Central Register of Clinical TrialsRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ministry of Health of the Russian FederationRussia: Pharmacological Committee, Ministry of HealthTurkey: Ethics CommitteeTurkey: Ministry of HealthUkraine: Ethics CommitteeUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women age = 18 years at data recording

• Hemodynamically stable nonvalvular AF or atrial flutter

• Documented LA/ LA thrombus on TEE

Exclusion Criteria:

• Valvular AF ( ESC 2012 definition)

• History of cardiac thrombus confirmed on TEE

• Intracardiac tumors, e.g. atrial myxoma

• Active endocarditis

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Other:
• no drug
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Bulgaria,  France,  Germany,  Poland,  Russian Federation,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombus resolution (completely disappeared) rate confirmed on TEE.		after 3-12 weeks of SoC treatment or lost to follow up, whichever is later	No
Secondary	Stroke or non central nervous system (CNS) systemic thromboembolism rate		after 3-12 weeks of SoC treatment or lost to follow up, whichever is later	No
Secondary	All bleeding (major, non-major, unknown severity) rates		after 3-12 weeks of SoC treatment or lost to follow up, whichever is later	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.