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TIMING of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02961348
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
The Swedish Stroke Register (Riksstroke)
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
This study will compare early with late start of treatment with Non-vitamin K oral anticoagulation (NOAC) in adult patients with acute ischemic stroke and atrial fibrillation; it is a registry-based randomized clinical trial (R-RCT) using The Swedish Stroke Register (Riksstroke). Half of the patients will start NOAC early (within 4 days after stroke onset) while the other half will start late (5-10 days after stroke onset).

Condition or disease Intervention/treatment Phase
Ischemic Stroke Atrial Fibrillation Other: Early start of NOAC Other: Late start of NOAC Not Applicable

Detailed Description:

Oral anticoagulation therapy is well established and highly recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation, but the optimal time point to start after an acute ischemic stroke is not known.

The intervention in this study will be timing of treatment onset. The choice of NOAC (i.e. apixaban, dabigatran, edoxaban or rivaroxaban) after the acute ischemic stroke is at the discretion of the treating physician.

This study will use the Swedish Stroke Register for enrolment, randomization and follow-up, with additional data linkage from other mandatory national registers. Primary outcome will be assessed at 90 days and secondary outcomes (including all-cause mortality and health economic analyses) and will be assessed at 90 days and up to one year after the index ischemic stroke.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Timing of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation: a Prospective Multicenter Registry-based Non-inferiority Randomized Controlled Clinical Trial
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early start of NOAC
Day 1 to day 4 after ischemic stroke onset
Other: Early start of NOAC
Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation

Active Comparator: Late start of NOAC
Day 5 to day 10 after ischemic stroke onset
Other: Late start of NOAC
Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation




Primary Outcome Measures :
  1. Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Recurrent acute ischemic stroke [ Time Frame: 90 days ]
    Defined as a new focal neurological deficit of sudden onset lasting at least 24 h (or <24 h if following therapeutic intervention, i.e. thrombolysis or thrombectomy, or if the deficit results in death < 24 h), occurring >24 hours after the index ischemic stroke, irrespective of vascular territory and that is not attributable to edema, brain shift, hemorrhagic transformation, intercurrent illness, hypoxia, or drug toxicity

  2. Symptomatic intracerebral hemorrhage (S-ICH) [ Time Frame: 90 days ]
    Defined as a new focal neurological deficit of sudden onset lasting at least 24 h with documented intracerebral hemorrhage (ICH) on imaging (computed tomography (CT) or magnetic resonance imaging (MRI)). Any intraparenchymal hematoma (≥10mm) will be considered, including hemorrhagic transformation of the index ischemic stroke. However microhemorrhages (<10mm) are not considered to be an ICH. ICH will be classified as symptomatic if it is associated with ≥4 points in total NIHSS or ≥2 points in one NIHSS category

  3. All-cause mortality [ Time Frame: 90 days ]
  4. Functional outcome [ Time Frame: 90 days ]
    Defined by grade on the modified Rankin Scale (mRS)

  5. Major hemorrhages [ Time Frame: 90 days ]
    Defined as bleedings that are fatal or life-threatening (according to the definition by the International Society on Thrombosis and Haemostasis) or lead to hospitalization



Information from the National Library of Medicine

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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:

  • Adult patients (≥ 18 years) with acute ischemic stroke and atrial fibrillation
  • Eligible and willing to start (or re-start) NOAC
  • Registered in The Swedish Stroke Register
  • Signed informed consent

Exclusion Criteria:

  • Contraindication to NOAC (e.g. ongoing bleeding, mechanical heart valve prosthesis)
  • Ongoing therapy with NOAC (without ≥2 days interruption at index stroke)
  • International normalized ratio (INR)>1.7
  • No second brain imaging (CT/MRI) after thrombolysis/thrombectomy
  • Previous randomization in the TIMING study

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): NCT02961348


Contacts
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Contact: Terese Karlin, MSc Pharm +46186170436 terese.karlin@ucr.uu.se
Contact: Signild Åsberg, MD. PhD signild.asberg@medsci.uu.se

Locations
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Sweden
Alingås Hospital Recruiting
Alingsås, Sweden
Principal Investigator: Brita Eklund         
Enköping Hospital Recruiting
Enköping, Sweden
Principal Investigator: Mikael Wiklund         
Mälarsjukhuset Hospital Recruiting
Eskilstuna, Sweden
Principal Investigator: Bo Danielsson         
Falu Hospital Recruiting
Falun, Sweden
Principal Investigator: Joakim Hambraeus         
Gälivare Hospital Recruiting
Gällivare, Sweden
Principal Investigator: Inari Toumikoski, MD         
Gävle Hospital Recruiting
Gävle, Sweden
Principal Investigator: Nikolaos Melas, MD         
Sahlgrenska University Hospital Östra Recruiting
Göteborg, Sweden
Principal Investigator: Anna-Clara Collén, MD         
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden
Principal Investigator: Annika Nordanstig, MD, PhD         
Hallands Hospital Recruiting
Halmstad, Sweden
Principal Investigator: Peter Thomasson Sommer         
Helsingborg Hospital Recruiting
Helsingborg, Sweden
Principal Investigator: Maria Macek, MD         
Karolinska University Hospital - Huddinge Recruiting
Huddinge, Sweden
Principal Investigator: Maria Lantz, MD         
Hässleholm Hospital Recruiting
Hässleholm, Sweden
Principal Investigator: Grodon Krzysztof         
Kalmar Hopsital Recruiting
Kalmar, Sweden
Principal Investigator: Claes Williamsson, MD         
Kiruna Hospital Recruiting
Kiruna, Sweden
Principal Investigator: Lacramioara Grosu, MD         
Kristianstad Hospital Withdrawn
Kristianstad, Sweden
Kungälv Hospital Recruiting
Kungälv, Sweden
Principal Investigator: Merja Henning         
Köping Hospital Recruiting
Köping, Sweden
Principal Investigator: Jan Saaf, MD         
Lindesberg Hospital Recruiting
Lindesberg, Sweden
Principal Investigator: Martin Johansson, MD         
Malmö University Hospital Recruiting
Malmö, Sweden
Principal Investigator: Eva Ask, MD         
Motala Hospital Recruiting
Motala, Sweden
Principal Investigator: Ulf Rosengren         
Sahlgrenska Universitetssjukhuset Mölndal Recruiting
Mölndal, Sweden
Principal Investigator: Carolina Sixt, MD         
Nyköping Hospital Recruiting
Nyköping, Sweden
Principal Investigator: Görel Wachtmeister         
Oskarshamn Hospital Recruiting
Oskarshamn, Sweden
Principal Investigator: Bongomin Churchill Otto         
Skaraborg Hospital Recruiting
Skövde, Sweden
Principal Investigator: Björn Cederin         
Karolinska University Hospital Recruiting
Solna, Sweden
Principal Investigator: Boris Keselman         
Capio S:t Görans Hospital Recruiting
Stockholm, Sweden
Principal Investigator: Ulrika Löfmark         
Danderyd University Hospital Recruiting
Stockholm, Sweden
Principal Investigator: Elisabeth Rooth         
Södersjukhuset Recruiting
Stockholm, Sweden
Principal Investigator: Mihaela Oana Romanitan, MD         
Sundsvall County Hospital Recruiting
Sundsvall, Sweden
Principal Investigator: Fredrick Björck         
University Hospital of Umeå Recruiting
Umeå, Sweden
Principal Investigator: Ola Lundström         
Uppsala University Hospital Recruiting
Uppsala, Sweden
Principal Investigator: Signild Åsberg         
Hallands Hospital Recruiting
Varberg, Sweden
Principal Investigator: Henrik Berntsson         
Västerås Hospital Recruiting
Västerås, Sweden
Principal Investigator: Andreas Ranhem, MD         
Örebro University Hospital Recruiting
Örebro, Sweden
Principal Investigator: Jakob Baianstovu Ström, MD         
Sponsors and Collaborators
Uppsala University
The Swedish Stroke Register (Riksstroke)
Investigators
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Principal Investigator: Jonas Oldgren, MD. PhD Dept of Medical Sciences, Uppsala University, Sweden
Principal Investigator: Signild Åsberg, MD. PhD Dept of Medical Sciences, Uppsala University, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02961348     History of Changes
Other Study ID Numbers: U-2015-341
2015-00881 ( Other Grant/Funding Number: The Swedish Research Council )
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Oral anticoagulants (NOAC)
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Atrial Fibrillation
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Anticoagulants