Antithrombotic Treatment Strategies in Cervical Artery Dissection (TREAT-CAD 2)
6. juni 2026 opdateret af: University Department of Geriatric Medicine FELIX PLATTER
Antiplatelet Versus Anticoagulation TREATment Strategies in Cervical Artery Dissection - TREAT-CAD 2 - A Multicenter, Randomized, Two-arm Parallel Group, Open-label, Blinded Endpoint, Pragmatic Trial
The goal of this clinical randomised controlled trial is to compare two treatment strategies - antiplatelet treatment strategy versus anticoagulation treatment strategy - in patients with acute, ischemic Cervical Artery Dissection (CAD). The study population includes patients presenting with any (clinical or imaging) signs of cerebral ischemia due to CAD.
The trial aims to estimate the net effect of antiplatelet versus anticoagulation treatment strategies on the composite primary outcome including recurrent ischemic stroke, major bleeding, or vascular death at 90 days (±2 weeks) after randomization.
Participants will:
- be randomly allocated to antiplatelet treatment strategy or anticoagulation treatment strategy
- receive treatment according to assigned strategy for the study period of 90 days
- be followed up for 90 days (±2 weeks) after randomization
- undergo clinical assessments to monitor for stroke recurrence, bleeding events, and vascular death Participant reported outcomes will be assessed both at 90 days (±2 weeks) and 12 months (± 4 weeks) after enrolment and will also expand to measures of quality of life and mental health outcomes.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1100
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Written informed consent (according to requirements by national legislation)
Onset/visualization of acute cerebral ischemia (≤ 3 days prior to randomization) attributable to CAD (either)
- CLINICAL ISCHEMIA: onset of acute ischemic stroke (including retinal infarct) or transient ischemic attack (including amaurosis fugax) attributable to CAD OR
- ISCHEMIA WITHOUT CORRESPONDING SYMPTOMS: visualization of acute ischemic lesion on diffusion weighted imaging attributable to CAD
Clinical MRI with suitable sequences for CAD diagnosis
- available OR
- scheduled to be performed before discharge (if not performed before enrolment)
Diagnosis of Cervical Artery Dissection (i.e. extracranial carotid and/or vertebral artery) by MRI/A or CTA based on the presence of the following criteria (at least one)
- Mural hematoma OR
- Long tapering stenosis OR
- Intimal flap OR
- Double lumen OR
- Flame-like occlusion of the dissected artery
Exclusion Criteria:
- Contraindications to either antiplatelets or oral anticoagulation therapy
- Other indication than CAD for full dose oral anticoagulation
- Contraindications for performance of MRI
- Age < 18 years
- Female patients who are either pregnant or breastfeeding (pregnancy testing prior to start of treatment will follow the standard operating procedures of clinical routine at participating sites)
Thrombolysis and/or endovascular treatment (EVT) is/are not considered an exclusion criterion.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Antiplatelet Treatment Strategy
|
Includes aspirin (ASA) or clopidogrel monotherapy or dual antiplatelet therapy (ASA + clopidogrel), at the choice of the treating physician but adhering to latest ESO guideline
|
|
Eksperimentel: Anticoagulation Treatment Strategy
|
Includes vitamin K antagonists (phenprocoumon, acenocoumarol, warfarin) with target INR 2.0-3.0 and heparin/LMWH bridging if needed or DOACs (apixaban, edoxaban, dabigatran, rivaroxaban) - at the choice of the treating physician but adhering to latest ESO guideline
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Net effect of antiplatelet treatment strategy versus anticoagulation treatment strategy
Tidsramme: From enrollment to day 90 (± 2 weeks)
|
The primary endpoint is a composite of the occurrence of (1) recurrent ischemic stroke, (2) major bleeding (extracranial or intracranial), or (3) vascular death
|
From enrollment to day 90 (± 2 weeks)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of each single component of the primary composite outcome measure
Tidsramme: From enrollment to day 90 (± 2 weeks)
|
From enrollment to day 90 (± 2 weeks)
|
|
|
- Functional neurological outcome (mRS)
Tidsramme: From enrollment to day 90 (± 2 weeks)
|
absolute difference and shift in favorable outcome (defined as mRS ≤ 2)
|
From enrollment to day 90 (± 2 weeks)
|
|
All-cause mortality
Tidsramme: From enrollment to day 90 (± 2 weeks)
|
From enrollment to day 90 (± 2 weeks)
|
|
|
Recurrence of Cervical Artery Dissection
Tidsramme: From enrollment to day 90 (± 2 weeks)
|
From enrollment to day 90 (± 2 weeks)
|
|
|
Patient-reported outcome measure on global health (PROMIS-10)
Tidsramme: From enrollment to day 90 (± 2 weeks)
|
From enrollment to day 90 (± 2 weeks)
|
|
|
Health related quality of life (EQ-5D Visual Analog scale)
Tidsramme: From enrollment to day 90 (± 2 weeks)
|
From enrollment to day 90 (± 2 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. marts 2030
Studieafslutning (Anslået)
1. marts 2030
Datoer for studieregistrering
Først indsendt
25. maj 2026
Først indsendt, der opfyldte QC-kriterier
6. juni 2026
Først opslået (Faktiske)
10. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-01009
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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