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| Name | Class |
|---|---|
| Swiss Stroke Trialist Association | UNKNOWN |
| Swiss Stroke Registry | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOAC+IVT | Acute ischemic Stroke patients with recent DOACs intake receive IVT. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase and Alteplase | Drug | The timepoints, dose, and type of IVT will be collected as well as any complications occuring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with symptomatic intracerebral hemorrhage (sICH) | 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) | Modified Rankin Scale from 0 (no disability) to 6 (death) | At day 90 or return to baseline (+/- 2 weeks) after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of IVT among IVT-eligible DOAC patients | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Meinel, MD, PhD | Contact | +41 31 66 4 25 67 | thomas.meinel@insel.ch | |
| Freschta Zipser-Mohammadzada, PhD | Contact | +41 31 63 2 60 83 | nctu@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Meinel, MD, PhD | Insel Gruppe AG, University Hospital Bern | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Not yet recruiting | Innsbruck | Austria |
IPDMA of similar observational cohort studies is planned.
After publication of primary study results
Ethics clearance, agreement with the DO-IT collaboration about terms of use and authorship
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| 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) | Modified Rankin Scale from 0 (no disability) to 6 (death) | At Day 90 (+/-2 weeks) after admission |
| Stroke severity (NIHSS) | 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) | At 24 hours ±8 hours |
| Cliniques Universitaires Saint Luc | Not yet recruiting | Brussels | Belgium |
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| UZ Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
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| The University of British Columbia | Vancouver General Hospital | Not yet recruiting | Vancouver | Canada |
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| CHU Caen | Not yet recruiting | Caen | France |
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| Nordwest-Krankenhaus Sanderbusch | Not yet recruiting | Sanderbusch | Germany |
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| Universitäsklinikum Tübingen | Not yet recruiting | Tübingen | Germany |
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| Dept. of Medicine, University of Thessaly | Recruiting | Larissa | Thessaly | 41110 | Greece |
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| A.O.R.N. Antonio Cardarelli Hospital | Not yet recruiting | Naples | Italy |
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| Ospedali Riuniti Hospital | Not yet recruiting | Palermo | Italy |
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| Ospedale "Bufalini", Cesena | Recruiting | Perugia | Italy |
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| AUSL-IRCCS di Reggio Emilia | Not yet recruiting | Reggio Emilia | Italy |
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| Akershus Hospital | Not yet recruiting | Oslo | Norway |
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| Hospital de Egas Moniz | Not yet recruiting | Lisbon | Portugal |
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| Clinical Centre of Serbia, University Hospital Belgrade | Recruiting | Belgrade | Serbia |
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| National University Hospital | Recruiting | Singapore | 119228 | Singapore |
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| Ljubljana University Medical Centre | Recruiting | Ljubljana | Slovenia |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| Hospital Universitari de Bellvitge | Not yet recruiting | Barcelona | Spain |
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| Kantonsspital Aarau | Recruiting | Aarau | Switzerland |
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| Unispital Basel | Recruiting | Basel | Switzerland |
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| Inselspital Bern, University Hospital Bern | Recruiting | Bern | Switzerland |
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| HFR Fribourg | Recruiting | Fribourg | Switzerland |
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| University Hospital Geneva | Recruiting | Geneva | Switzerland |
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| CHUV Lausanne | Recruiting | Lausanne | Switzerland |
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| Kantonsspital Lucerne | Recruiting | Lucerne | Switzerland |
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| EOC Lugano | Recruiting | Lugano | Switzerland |
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| Hôpital Neuchâtelois | Recruiting | Neuchâtel | Switzerland |
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| Kantonsspital St. Gallen | Recruiting | Sankt Gallen | Switzerland |
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| Hirslanden Zurich | Recruiting | Zurich | Switzerland |
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| University Hospital Zurich | Recruiting | Zurich | Switzerland |
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| Imperial College London NHS Trust | Not yet recruiting | London | United Kingdom |
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| King'S College Hospital Nhs Foundation Trust | Not yet recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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