Antithrombotic Treatment Strategies in Cervical Artery Dissection (TREAT-CAD 2)

June 6, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiplatelet Treatment Strategy
Procedure: 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
Experimental: Anticoagulation Treatment Strategy
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to day 90 (± 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of each single component of the primary composite outcome measure
Time Frame: From enrollment to day 90 (± 2 weeks)
From enrollment to day 90 (± 2 weeks)
- Functional neurological outcome (mRS)
Time Frame: 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
Time Frame: From enrollment to day 90 (± 2 weeks)
From enrollment to day 90 (± 2 weeks)
Recurrence of Cervical Artery Dissection
Time Frame: From enrollment to day 90 (± 2 weeks)
From enrollment to day 90 (± 2 weeks)
Patient-reported outcome measure on global health (PROMIS-10)
Time Frame: From enrollment to day 90 (± 2 weeks)
From enrollment to day 90 (± 2 weeks)
Health related quality of life (EQ-5D Visual Analog scale)
Time Frame: From enrollment to day 90 (± 2 weeks)
From enrollment to day 90 (± 2 weeks)

Collaborators and Investigators

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

Sponsor

University Department of Geriatric Medicine FELIX PLATTER

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

June 6, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026-01009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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