Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants (DO-IT Cohort)

August 13, 2024 updated by: Insel Gruppe AG, University Hospital Bern

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Freschta Zipser-Mohammadzada, PhD
  • Phone Number: +41 31 63 2 60 83
  • Email: nctu@insel.ch

Study Locations

  • Austria
      • Innsbruck, Austria
        • Not yet recruiting
        • Medical University of Innsbruck
        • Principal Investigator:
          • Christian Böhme, MD, PhD
  • Belgium
      • Brussel, Belgium
        • Not yet recruiting
        • Cliniques Universitaires Saint Luc
        • Contact:
          • Pasquale Scoppettuolo, MD
        • Principal Investigator:
          • Pasquale Scoppettuolo, MD
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Principal Investigator:
          • Robin Lemmens, Prof
  • Canada
      • Vancouver, Canada
        • Not yet recruiting
        • The University of British Columbia | Vancouver General Hospital
        • Contact:
          • Thalia Field
  • France
      • Caen, France
        • Not yet recruiting
        • CHU Caen
        • Principal Investigator:
          • Marion Boulanger, MD
  • Germany
      • Sanderbusch, Germany
        • Not yet recruiting
        • Nordwest-Krankenhaus Sanderbusch
        • Contact:
          • Pawel Kermer
        • Principal Investigator:
          • Pawel Kermer, MD
      • Tübingen, Germany
        • Not yet recruiting
        • Universitäsklinikum Tübingen
        • Principal Investigator:
          • Sven Poli, MD
        • Contact:
          • Julia Zeller
  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Recruiting
        • Dept. of Medicine, University of Thessaly
        • Principal Investigator:
          • George Ntaios, MD, PhD
        • Sub-Investigator:
          • Dimitra Papadimitriou, MD
  • Italy
      • Naples, Italy
        • Not yet recruiting
        • A.O.R.N. Antonio Cardarelli Hospital
        • Contact:
          • Paolo Candelaresi, MD
        • Principal Investigator:
          • Paolo Candelaresi, MD
      • Palermo, Italy
        • Not yet recruiting
        • Ospedali Riuniti Hospital
        • Contact:
          • Marina Mannino, MD
        • Principal Investigator:
          • Marina Mannino, MD
      • Perugia, Italy
        • Recruiting
        • Ospedale "Bufalini", Cesena
        • Contact:
        • Principal Investigator:
          • Michele Romoli, MD
      • Reggio Emilia, Italy
        • Not yet recruiting
        • AUSL-IRCCS di Reggio Emilia
        • Contact:
          • Marialuisa Zedde, MD
        • Principal Investigator:
          • Marialuisa Zedde
  • Norway
      • Oslo, Norway
        • Not yet recruiting
        • Akershus Hospital
        • Contact:
          • Espen Kristoffersen, MD
  • Portugal
      • Lisboa, Portugal
        • Not yet recruiting
        • Hospital de Egas Moniz
        • Contact:
        • Principal Investigator:
          • Joao Pedro Marto, MD
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Clinical Centre of Serbia, University Hospital Belgrade
        • Contact:
          • Visnja Padjen, MD
        • Principal Investigator:
          • Visnja Padjen, MD
  • Singapore
      • Singapore, Singapore, 119228
        • Recruiting
        • National University Hospital
        • Principal Investigator:
          • Benjamin Tan, MD
        • Contact:
          • Benjamin Tan, MD
        • Principal Investigator:
          • Mayank Dalakoti, MD
  • Slovenia
      • Ljubljana, Slovenia
        • Recruiting
        • Ljubljana University Medical Centre
        • Contact:
        • Principal Investigator:
          • Senta Frol, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de La Santa Creu I Sant Pau
        • Contact:
          • Marina Guasch-Jiménez, MD
        • Principal Investigator:
          • Marina Guasch-Jiménez, MD
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
          • Pere Cardona, MD
        • Principal Investigator:
          • Pere Cardona, MD
  • Switzerland
      • Aarau, Switzerland
        • Recruiting
        • Kantonsspital Aarau
        • Contact:
          • Timo Kahles
      • Basel, Switzerland
        • Recruiting
        • Unispital Basel
        • Contact:
          • Gerrit Grosse
      • Bern, Switzerland
        • Recruiting
        • Inselspital Bern, University Hospital Bern
        • Contact:
          • Freschta Zipser-Mohammadzada
      • Fribourg, Switzerland
        • Recruiting
        • Hfr Fribourg
        • Contact:
          • Friedrich Medlin
      • Geneva, Switzerland
        • Recruiting
        • University Hospital Geneva
        • Contact:
          • Emmanuel Carrera
      • Lausanne, Switzerland
        • Recruiting
        • CHUV Lausanne
        • Contact:
          • Patrik Michel
      • Lucerne, Switzerland
        • Recruiting
        • Kantonsspital Lucerne
        • Contact:
          • Manuel Bolognese
      • Lugano, Switzerland
        • Recruiting
        • EOC Lugano
        • Contact:
          • Carlo Cereda
      • Neuchâtel, Switzerland
        • Recruiting
        • Hôpital Neuchâtelois
        • Contact:
          • Susanne Renaud
      • St. Gallen, Switzerland
        • Recruiting
        • Kantonsspital St. Gallen
        • Contact:
          • Gian Marco De Marchis
      • Zurich, Switzerland
        • Recruiting
        • University Hospital Zurich
        • Contact:
          • Laura Westphal
      • Zurich, Switzerland
        • Recruiting
        • Hirslanden Zurich
        • Contact:
          • Nils Peters
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
          • Con Tibajia
      • London, United Kingdom
        • Not yet recruiting
        • Imperial College London NHS Trust
        • Contact:
          • Lucio D'Anna, MD
        • Principal Investigator:
          • Lucio D'Anna, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
DOAC+IVT
Acute ischemic Stroke patients with recent DOACs intake receive IVT.
Drug: Tenecteplase and Alteplase
The timepoints, dose, and type of IVT will be collected as well as any complications occuring.
DOAC
Acute ischemic Stroke patients with recent DOAC intake do not receive IVT.
IVT Controls
Acute ischemic Stroke patients without recent DOAC intake receive IVT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with symptomatic intracerebral hemorrhage (sICH)
Time Frame: Within 36 hours after IVT
Defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage.
Within 36 hours after IVT
Dichotomized good functional outcome (mRS 0-2)
Time Frame: At day 90 or return to baseline (+/- 2 weeks) after admission
Modified Rankin Scale from 0 (no disability) to 6 (death)
At day 90 or return to baseline (+/- 2 weeks) after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of IVT among IVT-eligible DOAC patients
Time Frame: Through study completion, an average of 2 years
To determine the rate of IVT in eligible patients with acute ischemic stroke and recent DOAC intake.
Through study completion, an average of 2 years
All-cause mortality, major bleeding and orolingual edema
Time Frame: From date of randomization until the date of all-cause mortality, major bleeding or orolingual edema, whichever came first, assessed up to 7 days.
From date of randomization until the date of all-cause mortality, major bleeding or orolingual edema, whichever came first, assessed up to 7 days.
Categorical shift in the modified Rankin Scale (mRS)
Time Frame: At Day 90 (+/-2 weeks) after admission
Modified Rankin Scale from 0 (no disability) to 6 (death)
At Day 90 (+/-2 weeks) after admission
Stroke severity (NIHSS)
Time Frame: At 24 hours ±8 hours
National Institutes of Health Stroke Scale from 0 (no symptoms) to 39 (most severe symptoms)
At 24 hours ±8 hours
Ischemic stroke volume at 24 hours (mL)
Time Frame: At 24 hours ±8 hours
At 24 hours ±8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss Stroke Trialist Association
Swiss Stroke Registry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Thomas Meinel, MD, PhD, Insel Gruppe AG, University Hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-01175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPDMA of similar observational cohort studies is planned.

IPD Sharing Time Frame

After publication of primary study results

IPD Sharing Access Criteria

Ethics clearance, agreement with the DO-IT collaboration about terms of use and authorship

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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