Clinical trial NCT06556446: Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
Official title: Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants: the DOAC - International Thrombolysis (DO-IT) Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: DOAC (Direct Oral AntiCoagulants)
NOAC (Novel Oral AntiCoagulants)
Anticoagulation
r-tPA (tissue-type plasminogen activator)
Alteplase
Tenecteplase
Rivaroxaban
Apixaban
Dabigatran
Edoxaban
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss Stroke Trialist Association
name: Swiss Stroke Registry
First posted: 2024-08-16
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The in- and exclusion criteria emulate a target trial, thus the investigators want to study a population that is - except from recent DOAC ingestion - eligible for IVT as per standard of care.

Brief summary: DO-IT is an international, prospective observational registry evaluating whether the administration of intravenous thrombolysis (IVT) is safe and improves functional outcome in ischemic stroke patients with recent direct oral anticoagulant (DOAC) intake. For this purpose, information on 2800 adult participants experiencing an acute ischemic stroke will be obtained at several high-volume international stroke centers and divided into three groups: IVT with recent DOACs intake (DOAC+IVT), and recent DOAC intake not receiving IVT (DOAC) as well as anonymized patients without DOAC receiving IVT. The patients are followed up for 90 days after the index event. treatment recommendations from the described observations. The investigators hypothesize that also more liberal decisions for IVT in patients with recent DOAC intake are not associated with an increased risk for symptomatic intracerebral hemorrhage (sICH) and result in better functional outcome at 3 month.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of acute ischemic stroke with indication for IVT according to applicable guidelines
2. Time from symptom onset or last known well \<12 hours
3. Admission NIHSS of 2 points or more
4. either DOAC ingestion within 48 hours prior to expected timepoint of IVT bolus, or patient with an ongoing prescription of DOAC, but exact timepoint of last intake not verifiable in the emergency setting. (regardless of whether intravenous thrombolysis was given) OR DOAC prescription (any intake within the last 7 days) and receiving intravenous thrombolysis
5. Informed consent (if obtainable and in those international sites where this is legally required) for the prospective part

Exclusion Criteria:

1. Patient refused the use of biological data for research purposes (Switzerland)
2. Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan
3. Documentation of any other absolute contraindications to IVT in the medical record
4. Significant pre-stroke disability (mRS score of 5), including known advanced dementia
5. Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
6. Pregnancy or lactating women.

Primary outcomes:
measure: Number of Participants with symptomatic intracerebral hemorrhage (sICH)
timeFrame: Within 36 hours after IVT
measure: Dichotomized good functional outcome (mRS 0-2)
timeFrame: At day 90 or return to baseline (+/- 2 weeks) after admission
Secondary outcomes:
measure: Rate of IVT among IVT-eligible DOAC patients
timeFrame: Through study completion, an average of 2 years
measure: All-cause mortality, major bleeding and orolingual edema
timeFrame: From date of randomization until the date of all-cause mortality, major bleeding or orolingual edema, whichever came first, assessed up to 7 days.
measure: Categorical shift in the modified Rankin Scale (mRS)
timeFrame: At Day 90 (+/-2 weeks) after admission
measure: Stroke severity (NIHSS)
timeFrame: At 24 hours ±8 hours
measure: Ischemic stroke volume at 24 hours (mL)
timeFrame: At 24 hours ±8 hours
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Vancouver
country: Canada
facility: The University of British Columbia | Vancouver General Hospital
city: Caen
country: France
facility: CHU Caen
city: Sanderbusch
country: Germany
facility: Nordwest-Krankenhaus Sanderbusch
city: Tübingen
country: Germany
facility: Universitäsklinikum Tübingen
city: Larissa
country: Greece
facility: Dept. of Medicine, University of Thessaly
state: Thessaly
city: Naples
country: Italy
facility: A.O.R.N. Antonio Cardarelli Hospital
city: Palermo
country: Italy
facility: Ospedali Riuniti Hospital
city: Perugia
country: Italy
facility: Ospedale "Bufalini", Cesena
city: Reggio Emilia
country: Italy
facility: AUSL-IRCCS di Reggio Emilia
city: Oslo
country: Norway
facility: Akershus Hospital
city: Lisboa
country: Portugal
facility: Hospital de Egas Moniz
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, University Hospital Belgrade
city: Singapore
country: Singapore
facility: National University Hospital
city: Ljubljana
country: Slovenia
facility: Ljubljana University Medical Centre
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Unispital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern, University Hospital Bern
city: Fribourg
country: Switzerland
facility: HFR Fribourg
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
city: Lucerne
country: Switzerland
facility: Kantonsspital Lucerne
city: Lugano
country: Switzerland
facility: EOC Lugano
city: Neuchâtel
country: Switzerland
facility: Hôpital Neuchâtelois
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: Hirslanden Zurich
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: London
country: United Kingdom
facility: Imperial College London NHS Trust
city: London
country: United Kingdom
facility: King'S College Hospital Nhs Foundation Trust
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Thomas Meinel, MD, PhD
role: STUDY_DIRECTOR
References: