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Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA)

Primary Purpose

Atrial Fibrillation, Stroke

Status

Active

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Apixaban

aspirin

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Pacemaker, Artificial, Defibrillators, Implantable, Atrial Fibrillation, Stroke Risk

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor capable of detecting SCAF
At least one episode of SCAF ≥ 6 minutes in duration but no single episode > 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average > 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration.
Age ≥ 55 years
Risk Factor(s) for Stroke:

Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors

Other risk factors are:

hypertension
CHF
diabetes
vascular disease (i.e. CAD, PAD or Aortic Plaque)
female

Exclusion Criteria:

Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms
Mechanical valve prosthesis, deep vein thrombosis, recent pulmonary embolism or other condition requiring treatment with an anticoagulant
Contra-indication to apixaban or aspirin:
1. Allergy to aspirin or apixaban
2. Severe renal insufficiency (creatinine clearance must be calculated in all patients; any patient with either a serum creatinine > 2.5 mg/dL [221 µmol/L] or a calculated creatinine clearance < 25 ml/min is excluded)
3. Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, platelet count < 50,000/mm3 or hemoglobin < 10 g/dL, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
4. Moderate to severe hepatic impairment
5. Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors)
6. Meets criteria for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of CYP 3A4 or P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
7. Ongoing need for strong dual inducers of CYP 3A4 or P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
Received an investigational drug in the past 30 days
Participants considered by the investigator to be unsuitable for the study for any of the following reasons:
1. Not agreeable for treatment with either aspirin or apixaban or anticipated to have poor compliance on study drug treatment
2. Unwilling to attend study follow-up visits
3. Life expectancy less than the expected duration of the trial2 years due to concomitant disease
Women who are pregnant, breast-feeding or of child-bearing potential without an acceptable form of contraception in place (sterilization, hormonal contraceptives, intrauterine device, barrier methods or abstinence)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Aspirin 81 mg once daily

Apixaban, 5 mg twice daily (or 2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)

Outcomes

Primary Outcome Measures

Composite of ischemic stroke and systemic embolism

Definition of stroke: Rapid onset* of a focal/global neurological deficit Duration of a focal/global neurological deficit ≥ 24 hours OR the neurological deficit results in death OR the neurological deficit is supported by clear evidence of cerebral infarction on diffusion-weighted MRI imaging. No other readily identifiable non-stroke cause for the clinical presentation Confirmation of the diagnosis by specialist evaluation or brain imaging procedure Definition of Systemic Embolism: Clinical signs and symptoms consistent with embolic arterial occlusion plus at least one of the following objective findings of arterial embolism: Surgical report indicating evidence of arterial embolism Pathological specimens related to embolism removal Imaging evidence consistent with arterial embolism Autopsy reports

Major Bleed

The main safety outcome will be the occurrence of clinically overt major bleeding as defined by the ISTH criteria: Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or Bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells.

Secondary Outcome Measures

Ischemic Stroke

Myocardial Infarction

MI definition: Typical rise and gradual fall (troponin) or more rapid rise and fall (CKMB) of biochemical markers of myocardial necrosis with at least one of: a) ischemic symptoms; b) development of pathological Q-waves on the ECG; c) ECG changes indicative of ischemia; d) Coronary artery intervention OR Pathological findings of an acute myocardial infarction

Cardiovascular Death

All-cause Death

Composite of stroke, MI, SE and death

Composite of stroke, myocardial infarction, systemic embolism and all-cause death

Composite of stroke, MI, SE, death and major bleeding

Composite of stroke, myocardial infarction, systemic embolism, all-cause death and major bleeding

Full Information

NCT ID

NCT01938248

First Posted

September 4, 2013

Last Updated

September 26, 2022

Sponsor

Population Health Research Institute

Collaborators

Bristol-Myers Squibb, Pfizer, Medtronic, Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT01938248

Brief Title

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

Acronym

ARTESiA

Official Title

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 2015 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Population Health Research Institute

Collaborators

Bristol-Myers Squibb, Pfizer, Medtronic, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.

Detailed Description

Device-detected sub-clinical atrial fibrillation (SCAF) is a new disorder that has been recognized since the availability of implantable devices capable of long term continuous heart rhythm monitoring. It is characterized by one or more runs of rapid atrial arrhythmia detected by the device without symptoms and without any clinical atrial fibrillation (AF) detected by the usual methods, (i.e. electrocardiogram, Holter monitor, etc.). In the ASSERT trial, SCAF was detected by a pacemaker or implantable cardioverter defibrillator (ICD) in nearly 40% of patients during 2 and a half years of follow up. The presence of SCAF increased stroke risk by 2.5-fold (1). The risk of stroke or systemic embolism among patients with SCAF and a CHADS2 score ≥ 4 was 2.75% per year. Oral anticoagulation is effective and safe for stroke prevention in patients with clinical atrial fibrillation, but it is unknown if the same risk benefit ratio exists for anticoagulation therapy in patients with SCAF (2;3). SCAF differs from clinical AF in being of shorter duration, being asymptomatic, and often have a more regular rhythm in the right atrium where it is typically detected. Data ASSERT suggest that the increase in stroke risk with SCAF may be less than the increase with clinical AF. Therefore opinion leaders have written that the role of oral anticoagulation for the treatment of SCAF is uncertain and that randomized trials of anticoagulation are needed (4;5). Recent surveys of pacemaker clinic practice indicate that only 25% of patients with SCAF are treated with oral anticoagulation (6;7). Thus there is clinical equipoise for a trial of oral anticoagulation compared to aspirin in higher risk patients with SCAF. Apixaban is a Factor Xa inhibitor that is an effective and safe anticoagulant. It has been shown to have an excellent risk benefit profile for stroke prevention in clinical AF (14, 15). It is highly suitable to test if oral anticoagulation therapy will reduce the risk of stroke or systemic embolism in SCAF. Patients will be randomized double-blind to receive apixaban or aspirin. Apixaban dose will be 5 mg twice daily (2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L). Those assigned to aspirin will receive a dose of 81 mg daily. The study will be event driven and will continue until 248 patients have experienced a primary outcome event.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Stroke

Keywords

Pacemaker, Artificial, Defibrillators, Implantable, Atrial Fibrillation, Stroke Risk

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4012 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Aspirin 81 mg once daily

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Apixaban, 5 mg twice daily (or 2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)

Intervention Type

Drug

Intervention Name(s)

Apixaban

Other Intervention Name(s)

Eliquis

Intervention Description

apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)

Intervention Type

Drug

Intervention Name(s)

aspirin

Other Intervention Name(s)

ASA, acetylsalicylic acid

Intervention Description

aspirin 81 mg once daily

Primary Outcome Measure Information:

Title

Composite of ischemic stroke and systemic embolism

Description

Time Frame

event driven, duration of follow-up - mean follow-up time anticipated: 3 years

Title

Major Bleed

Description

Time Frame

duration of follow-up

Secondary Outcome Measure Information:

Title

Ischemic Stroke

Time Frame

Duration of Follow-up

Title

Myocardial Infarction

Description

Time Frame

Duration of follow-up

Title

Cardiovascular Death

Time Frame

Duration of follow-up

Title

All-cause Death

Time Frame

Duration of follow-up

Title

Composite of stroke, MI, SE and death

Description

Composite of stroke, myocardial infarction, systemic embolism and all-cause death

Time Frame

Duration of follow-up

Title

Composite of stroke, MI, SE, death and major bleeding

Description

Composite of stroke, myocardial infarction, systemic embolism, all-cause death and major bleeding

Time Frame

Duration of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor capable of detecting SCAF At least one episode of SCAF ≥ 6 minutes in duration but no single episode > 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average > 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration. Age ≥ 55 years Risk Factor(s) for Stroke: Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors Other risk factors are: hypertension CHF diabetes vascular disease (i.e. CAD, PAD or Aortic Plaque) female Exclusion Criteria: Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms Mechanical valve prosthesis, deep vein thrombosis, recent pulmonary embolism or other condition requiring treatment with an anticoagulant Contra-indication to apixaban or aspirin: Allergy to aspirin or apixaban Severe renal insufficiency (creatinine clearance must be calculated in all patients; any patient with either a serum creatinine > 2.5 mg/dL [221 µmol/L] or a calculated creatinine clearance < 25 ml/min is excluded) Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, platelet count < 50,000/mm3 or hemoglobin < 10 g/dL, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias) Moderate to severe hepatic impairment Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors) Meets criteria for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of CYP 3A4 or P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin) Ongoing need for strong dual inducers of CYP 3A4 or P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) Received an investigational drug in the past 30 days Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Not agreeable for treatment with either aspirin or apixaban or anticipated to have poor compliance on study drug treatment Unwilling to attend study follow-up visits Life expectancy less than the expected duration of the trial2 years due to concomitant disease Women who are pregnant, breast-feeding or of child-bearing potential without an acceptable form of contraception in place (sterilization, hormonal contraceptives, intrauterine device, barrier methods or abstinence)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeff Healey, M.D.

Organizational Affiliation

Population Health Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stuart Connolly, M.D.

Organizational Affiliation

Population Health Research Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marco Alings, M.D.

Organizational Affiliation

Working Group Cardiovascular Research Netherlands

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Renato Lopes, M.D.

Organizational Affiliation

Duke Clinical Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiovascular Associates of Mesa, PC

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

St. Vincent Heart Clinic

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Cardiovascular Associates of Marin and San Francisco Medical

City

Larkspur

State/Province

California

ZIP/Postal Code

94939

Country

United States

Facility Name

Aurora Denver Cardiology Associates

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Naples Interventional Cardiac Electrophysiology

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Langhorne Cardiology Consultants, Inc.

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32501

Country

United States

Facility Name

One Health Cardiology, Owensboro Health, Inc.

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42304

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Sparrow Clinical Research Institute

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48912

Country

United States

Facility Name

Michigan Heart

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

University of Missouri Health System

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

St. Louis Heart and Vascular

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63136

Country

United States

Facility Name

Glacier View Cardiology

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

The Cooper Health System

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Facility Name

Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

The Valley Hospital

City

Ridgewood

State/Province

New Jersey

ZIP/Postal Code

07450

Country

United States

Facility Name

St. Peter's Health Partners Medical Association, PC

City

Albany

State/Province

New York

ZIP/Postal Code

12205

Country

United States

Facility Name

Carolinas Healthcare System

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

WakeMed

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27610

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Pennsylvania State University

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Research Institute of LG Health / Penn Medicine

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17602

Country

United States

Facility Name

Virginia Heart

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Onze Lieve Vrouw Ziekenhuis

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Vivalia CSL St. Joseph

City

Arlon

ZIP/Postal Code

6700

Country

Belgium

Facility Name

Clinique Saint Jean-Brussels

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Grand Hopital de Charleroi

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

AZ Groeninge

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

University Hospitals Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHC Saint Joseph

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

CHR de la Citadelle

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

AZ Delta

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

CHU Dinant-Godinne

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

University of Calgary Foothills Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

Royal Alexandra Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H 3V9

Country

Canada

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Grey Nuns Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6L 5X8

Country

Canada

Facility Name

Heart Rhythm Research Office - St. Paul's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6E 1M7

Country

Canada

Facility Name

Victoria Cardiac Arrhythmia Trials, Inc.

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8T 1Z4

Country

Canada

Facility Name

St. Boniface Hospital

City

Winnepeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Facility Name

Capital District Health Authority

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

St. Mary's General Hospital

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 1B2

Country

Canada

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

Country

Canada

Facility Name

Southlake Regional Health Centre

City

Newmarket

State/Province

Ontario

Country

Canada

Facility Name

Oakville Cardiologists

City

Oakville

State/Province

Ontario

Country

Canada

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

Health Sciences North

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Sunnybrook Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Institute Universitaire de Cardiologie and de Pneumonologie

City

Laval

State/Province

Quebec

Country

Canada

Facility Name

McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

CHUM - Hotel Dieu

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Hopital Sacre-Coeur de Montreal

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Montreal Heart Institute

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

CHUS - Sherbrooke

City

Sherbrooke

State/Province

Quebec

Country

Canada

Facility Name

Ciusss McQ

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8Z 3R9

Country

Canada

Facility Name

IKEM Institute for Clinical and Experimental Medicine

City

Prague

ZIP/Postal Code

14021

Country

Czechia

Facility Name

Hilleroed Hospital

City

Hilleroed

State/Province

North Zealand

ZIP/Postal Code

3400

Country

Denmark

Facility Name

Sygehus Sonderjylland

City

Aabenraa

ZIP/Postal Code

6200

Country

Denmark

Facility Name

Aalborg University Hospital, Dept of Cardiology

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Aarhus Unniversity Hospital, Skejby

City

Aarhus

ZIP/Postal Code

DK-8200

Country

Denmark

Facility Name

Gentofte Hospital

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Hjertemedicinsk Forskning, RH Viborg, HEM

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Johann Wolfgang Goethe University Hospital Frankfurt

City

Frankfurt

State/Province

Hesse

ZIP/Postal Code

60590

Country

Germany

Facility Name

Katholisches Klinikum Mainz

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Universitatsklinikum des Saarlandes

City

Homburg/Saar

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Facility Name

MVZ am Kuchwald GmbH

City

Chemnitz

State/Province

Saxony

ZIP/Postal Code

09113

Country

Germany

Facility Name

Zentrum fur klinische Prufungen in der Facharztzentrum Dresd

City

Dresden

State/Province

Saxony

ZIP/Postal Code

01099

Country

Germany

Facility Name

University Medicine Gottingen

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Asklepios Klinik Barmbek

City

Hamburg

ZIP/Postal Code

22291

Country

Germany

Facility Name

Universitaetsklinikum Tuebingen, Kardiologie

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Allami Szivkorhaz Balatonfured

City

Balatonfured

State/Province

Veszprem

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Magyar Honvedseg Egeszsegugyi Kozpont

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Semmelweis University

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

Ospedale Sant'Anna

City

San Fermo Della Batt

State/Province

Como

ZIP/Postal Code

22020

Country

Italy

Facility Name

Cardiologia-A.O. Desio e Vimercate - Presisio di Vimercat

City

Vimercate

State/Province

Monza Brianza MB

ZIP/Postal Code

20871

Country

Italy

Facility Name

Hospital Santa Maria Della Pieta

City

Nola

State/Province

Napoli

ZIP/Postal Code

80035

Country

Italy

Facility Name

AOU Ospedali Riuniti

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Ospedale Maggiore, Cardiologia Dept.

City

Bologna

ZIP/Postal Code

40133

Country

Italy

Facility Name

S.Orsola-Malpighi

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Bolzano Regional Hospital, Dept of Cardiology

City

Bolzano

ZIP/Postal Code

39100

Country

Italy

Facility Name

Azienda Ospedaliero-Univeritaria Di Modena-Policlinico

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Ospedale G.B. Grassi

City

Rome

ZIP/Postal Code

00122

Country

Italy

Facility Name

University and Hospital of Trieste

City

Trieste

ZIP/Postal Code

34129

Country

Italy

Facility Name

Ziekenhuis Tjongerschans

City

Heerenveen

State/Province

Friesland

ZIP/Postal Code

8441 PW

Country

Netherlands

Facility Name

Gelre Ziekenhuis

City

Zutphen

State/Province

Gelderland

ZIP/Postal Code

7207 AE

Country

Netherlands

Facility Name

Atrium Orbis Heerlen

City

Heerlen

State/Province

Limburg

ZIP/Postal Code

6419 PC

Country

Netherlands

Facility Name

Amphia Hospital Breda

City

Breda

State/Province

Noord-Brabant

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Ikazia Ziekenhuis

City

Rotterdam

State/Province

Zuid-Holland

ZIP/Postal Code

3083 AN

Country

Netherlands

Facility Name

BovenIJ Ziekenhuis

City

Amsterdam

ZIP/Postal Code

1034 CS

Country

Netherlands

Facility Name

Hospital Rijnstate

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Deventer Hospital, Cardiology Research

City

Deventer

ZIP/Postal Code

7416 SE

Country

Netherlands

Facility Name

Hospital Gelderse Vallei

City

Ede

ZIP/Postal Code

6721 JT

Country

Netherlands

Facility Name

Treant Hospital Department Cardiology

City

Emmen

ZIP/Postal Code

7824 AA

Country

Netherlands

Facility Name

Admiraal de Ruyter Ziekenhuis

City

Goes

ZIP/Postal Code

4462 RA

Country

Netherlands

Facility Name

Treant Hospital - Bethseda, Hoogeveen

City

Hoogeveen

ZIP/Postal Code

7909 AA

Country

Netherlands

Facility Name

Bravis Ziekenhuis, locatie Roosendaal

City

Roosendaal

ZIP/Postal Code

4708 AE

Country

Netherlands

Facility Name

(ETZ) Elisabeth Tweesteden Hospital

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Máxima Medisch Centrum

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

Barum Hospital, Vestre Viken

City

Drammen

State/Province

Buskerud

ZIP/Postal Code

3004

Country

Norway

Facility Name

Oslo University Hospital - Ulleval

City

Oslo

ZIP/Postal Code

0450

Country

Norway

Facility Name

Hospital Clinico Santiago de Compostela

City

Santiago De Composte

State/Province

A Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Rafael Mendez Universitary Hospital

City

Lorca

State/Province

Murcia

ZIP/Postal Code

30800

Country

Spain

Facility Name

Complexo Hospitalario Universitario A Coruna

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital General Universitario de Alicante

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Hospital Del Mar

City

Barcelona

ZIP/Postal Code

8003

Country

Spain

Facility Name

Hospital Juan Ramon Jimenez

City

Huelva

ZIP/Postal Code

21005

Country

Spain

Facility Name

Hospital Clinico San Carlos, Unidad De Arritmias

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Puerta de Hierro Majadahonda

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

Agencia Sanitaria Costa del Sol- Hospital Costa del Sol

City

Marbella

ZIP/Postal Code

29603

Country

Spain

Facility Name

Clinica Universidad de Navarra

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital Clinico Universitario de Valencia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hospital Clínico Universitario de Valladolid

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Name

University Hospital Basel

City

Basel

State/Province

Basel-Stadt

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Kantonsspital St Gallen

City

St. Gallen

State/Province

Saint Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

CHUV

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Hopital Fribourgeois, site de Fribourg

City

Fribourg

ZIP/Postal Code

1708

Country

Switzerland

Facility Name

University Hospital of Geneva

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Dorset County Hospital NHS Foundation Trust

City

Dorchester

State/Province

Dorset

ZIP/Postal Code

DT12JY

Country

United Kingdom

Facility Name

Hampshire Hospitals (NHS Foundation Trust)

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Portsmouth Hospitals NHS Trust

City

Portsmouth

State/Province

Hampshire

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Royal Alexandra Hospital

City

Paisley

State/Province

Renfrewshire

ZIP/Postal Code

PA29PN

Country

United Kingdom

Facility Name

Shrewsbury & Telford Hospital NHS

City

Shropshire

State/Province

West Midlands

ZIP/Postal Code

TF1 6TF

Country

United Kingdom

Facility Name

Blackpool Teaching Hospitals NHS Foundation Trust

City

Blackpool

ZIP/Postal Code

FY3 8NR

Country

United Kingdom

Facility Name

Queen Elizabeth University Hospital

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Liverpool Heart and Chest Hospital

City

Liverpool

ZIP/Postal Code

L14 3PE

Country

United Kingdom

Facility Name

Freeman Hospital

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

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Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA)

Atrial Fibrillation, Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial