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Apixaban for Treatment of Embolic Stroke of Undetermined Source (ATTICUS)

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ClinicalTrials.gov Identifier: NCT02427126
Recruitment Status : Recruiting
First Posted : April 27, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active controlled, efficacy study (phase III)

Condition or disease Intervention/treatment Phase
Embolic Stroke Drug: Apixaban Drug: Aspirin Phase 3

Detailed Description:

Based on the previous data, ATTICUS is designed as multicentre, national, parallel groupactive controlled, phase III randomized (2x2 factorial), clinical trial to demonstrate the superiority of apixaban against the current standard of treatment (acetylsalicylic acid) for the longterm treatment after ESUS. ATTICUS will follow a dynamic treatment protocol implementing conversion from the acetylsalicylic acid arm to the apixaban arm in case of detection of relevant episodes of AF during the course of the study.

! ATTICUS is designed to test the superiority over acetylsalicylic acid to reduce new ischemic lesion detected by FLAIR/DWI MRI.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apixaban for Treatment of Embolic Stroke of Undetermined Source (ATTICUS Randomized Trial)
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apixaban
Apixaban 5mg b.i.d. Study treatment: 12 months Follow-up: 30 days after last study drug intake
Drug: Apixaban
Apixaban is an oral anticoagulant currently approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, for the treatment of deep vein thrombosis and pulmonary embolism, and for the prophylaxis of systemic embolism after orthopedic surgery
Other Name: Eliquis

Active Comparator: Aspirin
Acetylic Salicylic Acid 100mg o.d.; Study treatment: 12 months Follow-up: 30 days after last study drug intake
Drug: Aspirin
Acetylic Salicylic Acid 100mg o.d.; 12 Months




Primary Outcome Measures :
  1. Occurrence of at least one new ischemic lesion identified by magnetic resonance imaging at 12 months when compared to the baseline MRI (FLAIR, DWI) obtained at the time of study drug initiation. [ Time Frame: 12 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria Must be ≥ 18 years at the time of signing the informed consent.

  • ESUS must be defined according to following criteria:

    • Stroke detected by CT or MRI that is not lacunar
    • Absence of extracranial or intracranial atherosclerosis causing ≥50% luminal stenosis in arteries supplying the area of ischaemia
    • No major-risk cardioembolic source of embolism
    • No other specific cause of stroke identified
  • * At least one of the following non-major but suggestive risk factors for cardiac embolism:

    • LA size >45mm (parasternal axis)
    • spontaneous echo contrast in LAA
    • LAA flow velocity <=0.2m/s
    • atrial high rate episodes
    • CHA2DS2-Vasc score >=4
    • persistent foramen ovale
  • Understand and voluntarily sign an informed consent document
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception.

Exclusion Criteria:

  • History of hypersensitivity to the investigational medicinal product
  • Participation in other clinical trials or observation period of competing trials.
  • Arteria cerebri media stroke affecting > 30% of c o r r e s p o n d i n g territory
  • Diagnosis of haemorrhage or other pathology,
  • Clear indication for anticoagulation
  • Inability to control following risk factors for Hemorrhagic Transformation of fresh cerebral Infarction (HTI) during index hospital stay: presence of HTI at the time of anticoagulation, blood pressure >140 mmHg systolic, abnormal blood glucose Clear indication for dual antiplatelet therapy
  • Clear stroke-/non-stroke-indication for concomitant long-term therapy with antiplatelets (e.g. acetylsalicylic acid (ASA), Clopidogrel, or Prasugrel) or with non-steroidal anti-inflammatory drugs (NSAID).
  • Concomitant systemic therapy with strong inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. azoleantimycotics and human immunodeficiency virus (HIV)-protease inhibitors.
  • Contraindication to investigational medications
  • Planned or likely therapy with fibrinolytic agents within 48 hours of first study medication
  • History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
  • Gastrointestinal bleed or major surgery within 3 months
  • Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
  • TIA or minor stroke induced by angiography or surgery
  • Severe non-cardiovascular comorbidity with life expectancy < 3 months
  • Severe renal failure, defined as Glomerular Filtration Rate (GFR) <15ml/min
  • Severe hepatic insufficiency (Child-Pugh score B to C),
  • Active liver disease,
  • Contraindications against performance of MRI (pacemaker/ICD), previous implantation non-MRI capable protheses
  • Patients considered unreliable by the investigator, or having a life expectancy less than the expected duration of the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427126


Contacts
Contact: Tobias Geisler, Prof 0049 ( 0) 7071 29 87320 tobias.geisler@med.uni-tuebingen.de
Contact: Ulf Ziemann, Prof 0049 ( 0) 7071 29 82049 Ulf.Ziemann@med.uni-tuebingen.de

Locations
Germany
Klinik für NeurologieKnappschaftskrankenhaus Bochum-Langendreer Recruiting
Bochum, Germany
Contact: Uwe Schlegel, MD         
Neurologische Klinik, Universität Bonn Recruiting
Bonn, Germany
Contact: Gabor Petzold, Dr. med.         
Klinikum Coburg GmbH II Recruiting
Coburg, Germany
Contact: Johannes Brachmann, Prof         
Neurologie, Klinikum Friedrichshafen GmbH Recruiting
Friedrichshafen, Germany
Contact: R Huber, Prof         
Universitätsmedizin GöttingenAbt. Innere Medizin, Klinik für Kardiologie und Pneumologie, Recruiting
Göttingen, Germany
Contact: Rolf Wachter, MD         
Neurologische Klinik Städtische Kliniken Karlsruhe,Städtisches Klinikum Karlsruhe gGmbH Not yet recruiting
Karlsruhe, Germany
Contact: Gahn, Prof         
Klinik für Neurolgie,UKSH Campus Kiel Not yet recruiting
Kiel, Germany
Contact: Andreas Binder, MD         
Klinik für Neurologie, Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany
Contact: Martin Schabet, Prof         
Carl von Basedow KlinikumSaalekreis gGmbH Not yet recruiting
Merseburg, Germany
Contact: Carsten Hobohm, MD         
Marienhospital Stuttgart, Klinik für Neurologie Recruiting
Stuttgart, Germany
Contact: Alfred Lindner, Prof         
Neurologische Klinik des Bürgerhospitals Recruiting
Stuttgart, Germany
Contact: Elisabeth Schmid, Dr. med.         
University Hospital Recruiting
Tubingen, Germany, D72076
Contact: Tobias Geisler, Prof         
Contact: Timea Keller, Mrs         
Principal Investigator: Tobias Geisler, Prof         
Sub-Investigator: Sven Poli, MD         
Sub-Investigator: Jürgen Schreieck, MD         
Universitäts- und Rehabilitationskliniken Ulm,Klinik für Neurologie Recruiting
Ulm, Germany
Contact: Katharina Althaus, Dr         
Schwarzwald Baar Klinikum GmbH Recruiting
Villingen-Schwenningen, Germany
Contact: Werner Jung, Prof         
Rems-Murr-Klinikum WinnendenNeurologie Recruiting
Winnenden, Germany
Contact: Fabian Hillenbrand, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Tobias Geisler, Prof Tübingen University Hospital

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02427126     History of Changes
Other Study ID Numbers: 2014-005109-19
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Apixaban
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants