Study of alteplase and tenecteplase for intravenous thrombolysis in patients with ischemic stroke who are taking direct oral anticoagulants

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What is this study about?

This study focuses on patients with acute ischemic stroke who are taking direct oral anticoagulants. An ischemic stroke occurs when a blood clot blocks blood flow to part of the brain. The study examines two medications used for dissolving blood clots: alteplase and tenecteplase, which are given through an intravenous injection into a vein.

The purpose of this research is to determine if using these clot-dissolving medications leads to better recovery in stroke patients who are already taking blood-thinning medicines. The medications will be compared to standard care treatment to see if they can improve patients’ ability to perform daily activities after their stroke.

During the study, participants will receive either one of the clot-dissolving medications or standard care treatment. The treatment must be given within 4.5 hours of when stroke symptoms begin. Doctors will monitor patients’ recovery and check for any bleeding complications. Follow-up assessments will be conducted over 90 days to evaluate how well patients recover from their stroke.

1 Initial assessment and treatment

After experiencing symptoms of ischemic stroke and having taken blood-thinning medication within the last 48 hours, you will receive an assessment to determine eligibility for treatment.

If eligible, you will receive one of two medications through an intravenous injection (directly into your vein): either alteplase or tenecteplase.

Treatment must begin within 4 hours and 30 minutes of the last time you were known to be well, or within 4.5 hours if specific brain imaging criteria are met.

2 24-hour evaluation

After approximately 24 hours (±12 hours), you will undergo an assessment of your stroke severity.

The medical team will check for any potential bleeding complications.

Brain imaging may be performed to measure the size of the affected area.

3 36-hour safety check

The medical team will monitor for any signs of bleeding in the brain during the first 36 hours after treatment.

4 7-day follow-up

Your condition will be monitored for up to 7 days or until hospital discharge.

The medical team will record any significant health events during this period.

5 90-day final assessment

A final evaluation will take place approximately 90 days (±2 weeks) after treatment.

This assessment will include checking your level of independence in daily activities.

You will complete a quality of life questionnaire to evaluate your overall well-being.

Who Can Join the Study?

Patient must provide informed consent to participate in the study (in some cases, consent may be obtained later as allowed by national law)
Patient must have an acute ischemic stroke (a type of stroke caused by blocked blood flow to the brain) that qualifies for treatment with clot-dissolving medications according to the doctor’s assessment
Patient must have taken direct oral anticoagulants (blood-thinning medications) within the last 48 hours, or be currently prescribed these medications even if exact time of last dose is unknown
Patient must meet ONE of these timing requirements:
- Can start treatment within 4 hours and 30 minutes from when symptoms began, OR
- Have specific brain MRI findings showing signs of a recent stroke (within 4.5 hours) and can start treatment within 4.5 hours of when symptoms were first noticed
Both men and women can participate in the study
Adults of all ages can participate

Who Cannot Join the Study?

Patient age below 18 years or above 85 years
Patients who have not taken direct oral anticoagulants (blood-thinning medications) recently
Patients who have conditions other than acute ischemic stroke (blocked blood flow to the brain)
Patients who are not eligible for intravenous thrombolysis (clot-dissolving treatment) according to local care standards
Patients unable to provide informed consent
Patients who cannot be followed up for 90 days after treatment
Patients currently participating in other clinical trials
Patients with severe kidney or liver disease
Patients with active bleeding
Patients with a history of brain hemorrhage
Patients with blood pressure that cannot be controlled to acceptable levels
Pregnancy or breastfeeding
Known allergy to the study medications (alteplase or tenecteplase)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert	Belgium
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Haga Hospital	Hague	The Netherlands
Hospital Vall d’Hebron	Barcelona	Spain
Hospital Universitario da A Coruna	A Coruna Galicia	Spain
Medical University Of Vienna	Vienna	Austria
Amsterdam UMC	Amsterdam	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Medical University Of Graz	Graz	Austria
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)	Rotterdam	The Netherlands
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Hospices Civils De Lyon	Lyon	France
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Maastricht	Maastricht	The Netherlands
Universitaet Leipzig	Leipzig	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Universitair Medisch Centrum Groningen	Groningen	The Netherlands
Amphia Hospital	Breda	The Netherlands
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre	STRASBOURG, Alsace	France
Hopital Saint Eloi	Montpellier	France
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Saarland University Hospital	Homburg	Germany
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Ludwig Maximilian University Of Munich	Munich	Germany
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience	Paris	France
Leids Universitair Medisch Centrum (LUMC)	Leiden	The Netherlands
Rijnstate Ziekenhuis Stichting	Arnhem	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d’Oncología (ICO)	Badalona	Spain
GHU St Anne Psychiatrie et Neurosciences	Paris	France
Stichting OLVG	Amsterdam	The Netherlands

Other Sites

Site Name	City	Country
Hôpital Foch	Suresnes	France
Medical Center Haaglanden	Hague	The Netherlands
Centro Hospitalar Universitario Lisboa Central E.P.E.	Lisbon	Portugal
HELIOS Klinik Schleswig GmbH	Schleswig	Germany
Universitätsklinikum Freiburg	Freiburg Im Breisgau	Germany
Universitätsmedizin Frankfurt	Frankfurt	Germany
RHÖN-KLINIKUM AG – Campus Bad Neustadt	Bad Neustadt A.D.Saale	Germany
AP-HP, Pitié-Salpêtrière	Paris	France
Fransciscus Gasthuis	Rotterdam	The Netherlands
CHU de Liège	Liege	Belgium
Kkfjprsc Kxigks Gzec	Kassel	Germany
Pjsxxnqkv Hjfxxylm	Bordeaux	France
Cfha Nlruw	Nancy	France
Krvpwpuesvb Dwc Bgcupcuilrgz Bgymzo Eodyqthrkq Gkbc	Eisenstadt	Austria
Sde Ktzidett Kxvlqsdncsijnwwocbtuyacd Gdnl	Karlsbad	Germany
Cxt dt Cekkpsnfx Hmcyrpl Cyboq Myatr Cpjdg	Charleroi	Belgium
Ap Glgeopufx	Kortrijk	Belgium
Rhwnntu Uxylmpqvoi Nxrxqlcg Msnxgdu Cjdibf	Nijmegen	The Netherlands
Noniotgguoqxpdknfohj Sqxbawvzair	Sande	Germany
Kyxljwyfwer Kkgyebgc Bkpzwpk Gubr	Bottrop	Germany
Ahuzkp Lpsummoworxv	Paris	France
Pzvvwtsjh Hsiynere Cdlvwo	Perpignan	France
Azushogq Uvplxevwor Hauhkpnn	Oslo	Norway
Ksjqbwsc dlm Sdolo Lygtxmviykdz aq Rssum gvbvq	Ludwigshafen Am Rhein	Germany
Huvpdi Kynnwkwa Egdzem Gtlh	Erfurt	Germany
Sob Jjtyxotgmjyfkh	Bochum	Germany
Uncgknv Lkiti Dd Sypda Dr Mloxntsxud Ecrktz	Senhora Da Hora	Portugal
Kbpwmdcrnto Doc Bqphwhbguklm Bpryivu Wxdc	Vienna	Austria
Uuogitlpdehxvwslgin Gveuqpujy	Goettingen	Germany
Uarsahhxjwuftedqrqtw Jqnv	Jena	Germany
Uqn dh Ewdmg Dsabf e Virdz	Santa Maria Da Feira	Portugal
Cyxlpppwa Dlzolto Kkpmzo	Salzburg	Austria
Shcj Koyzckrx Lzwesv Gjhv	Luebeck	Germany

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.04.2025
Belgium	Recruiting	01.04.2025
Finland	Recruiting	01.04.2025
France	Recruiting	01.04.2025
Germany	Recruiting	01.04.2025
Norway	Recruiting	01.04.2025
Portugal	Recruiting	01.04.2025
Spain	Recruiting	01.04.2025
The Netherlands	Recruiting	01.04.2025

Trial locations

Investigated Drugs:

Alteplase is a clot-busting medication that helps restore blood flow to the brain during an acute ischemic stroke. It works by breaking down blood clots that are blocking blood vessels. This medication is given through an intravenous (IV) line.

Tenecteplase is also a clot-dissolving medication used to treat ischemic stroke. Like alteplase, it works by breaking down blood clots, but it can be given as a single injection. It’s designed to be more specific to fibrin (the main component of blood clots) than alteplase.

Direct Oral Anticoagulants (DOACs) are blood-thinning medications that help prevent blood clots from forming. These medications are taken by mouth and work by interfering with specific proteins in the blood that are involved in clot formation. They are commonly used to prevent strokes in patients with certain heart conditions.

Investigated Diseases:

Ischaemic stroke

Acute Ischemic Stroke – A condition that occurs when blood flow to an area of the brain is blocked by a clot, preventing brain tissue from getting oxygen and nutrients. The blockage causes brain cells to begin dying within minutes. This condition develops suddenly and can affect different areas of the brain, leading to various neurological symptoms such as weakness on one side of the body, speech problems, or vision disturbances. The severity of symptoms depends on the location and size of the blocked area in the brain.

Trial ID:

2024-515561-34-01

Protocol code:

DO-IT

NCT ID:

NCT06571149

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of alteplase and tenecteplase for intravenous thrombolysis in patients with ischemic stroke who are taking direct oral anticoagulants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?