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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06571149




Registration number
NCT06571149
Ethics application status
Date submitted
22/08/2024
Date registered
26/08/2024

Titles & IDs
Public title
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
Scientific title
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: DO-IT - The DOAC Intravenous Thrombolysis Trial
Secondary ID [1] 0 0
2024-01157
Universal Trial Number (UTN)
Trial acronym
DO-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase or Alteplase

No intervention: Best Medical Treatment (standard of care) - Patients will receive Standard of care/Best medical treatment according to local applicable guidelines, including the current American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation/ European Society of Minimally Invasive Neurological Therapy (ESO/ESMINT) guidelines.

Experimental: Intravenous Thrombolysis + Best medical treatment (standard of care) - Patients will receive intravenous administration of Tenecteplase or Alteplase.


Treatment: Drugs: Tenecteplase or Alteplase
Patients randomized to intravenous thrombolysis (IVT) treatment will receive intravenous Tenecteplase or Alteplase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Scale (mRS)
Timepoint [1] 0 0
90 days +/- 2 weeks after randomization
Secondary outcome [1] 0 0
Dichotomized modified Rankin Scale (mRS) 0-2 (good functional outcome)
Timepoint [1] 0 0
90 days +/- 2 weeks post-randomization
Secondary outcome [2] 0 0
Change from baseline in stroke severity (National Institutes of Health Stroke Scale, NIHSS)
Timepoint [2] 0 0
24 +/- 12 hours after Intervention
Secondary outcome [3] 0 0
Health-related Quality of Life (EuroQol 5D-3L questionnaire)
Timepoint [3] 0 0
90 days +/- 2 weeks post-randomization

Eligibility
Key inclusion criteria
* Informed consent (deferred consent when possible according to national legislation)
* AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician
* DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.
* Either

* Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
* MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion =4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.
* Intended reversal by specific or unspecific reversal agents
* Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria

* Age > 55 years OR
* Age < 55 years and at least 12 months since last menstrual period OR
* Have had a documented surgical sterilization
* Patient < 18 years of age (since the benefit of IVT is unproven in this population)

Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:

* Intended treatment with endovascular reperfusion strategies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2029
Actual
Sample size
Target
906
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Greece
State/province [5] 0 0
Athens
Country [6] 0 0
Japan
State/province [6] 0 0
Kansai
Country [7] 0 0
Netherlands
State/province [7] 0 0
Amsterdam
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch
Country [9] 0 0
Norway
State/province [9] 0 0
Oslo
Country [10] 0 0
Portugal
State/province [10] 0 0
Lisbon
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Switzerland
State/province [12] 0 0
Basel
Country [13] 0 0
Switzerland
State/province [13] 0 0
St. Gallen

Funding & Sponsors
Primary sponsor type
Other
Name
Insel Gruppe AG, University Hospital Bern
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Meinel, MD, PhD
Address 0 0
Insel Gruppe AG, University Hospital Bern
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas Meinel, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+41 31 66 4 25 67
Fax 0 0
Email 0 0
thomas.meinel@insel.ch
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPDMA (individual participant data meta-analysis) of similar interventional clinical studies is planned.

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
After publication of primary study results
Available to whom?
Ethics clearance, agreement with the DO-IT collaboration about terms of use and authorship
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06571149