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NCT Number: NCT07639892

Antithrombotic Treatment Strategies in Cervical Artery Dissection

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.

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Key information

Conditions

Cervical Artery Dissection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antiplatelet Treatment Strategy

Procedure

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

Anticoagulation Treatment Strategy

Procedure

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

Primary outcomes

  1. Net effect of antiplatelet treatment strategy versus anticoagulation treatment strategy

    Time frame: 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

Secondary outcomes

  1. Occurrence of each single component of the primary composite outcome measure

    Time frame: From enrollment to day 90 (± 2 weeks)

  2. - Functional neurological outcome (mRS)

    Time frame: From enrollment to day 90 (± 2 weeks)

    absolute difference and shift in favorable outcome (defined as mRS ≤ 2)

  3. All-cause mortality

    Time frame: From enrollment to day 90 (± 2 weeks)

  4. Recurrence of Cervical Artery Dissection

    Time frame: From enrollment to day 90 (± 2 weeks)

  5. Patient-reported outcome measure on global health (PROMIS-10)

    Time frame: From enrollment to day 90 (± 2 weeks)

  6. Health related quality of life (EQ-5D Visual Analog scale)

    Time frame: From enrollment to day 90 (± 2 weeks)

Sponsors and collaborators

Lead sponsor

University Department of Geriatric Medicine FELIX PLATTER

Other

Registry information

Official study title

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

Acronym: TREAT-CAD 2

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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