Cervical Artery DissectionTREAT-CAD 2NCT07639892
Antithrombotic Treatment Strategies in Cervical Artery Dissection
A study testing Antiplatelet Treatment Strategy and Anticoagulation Treatment Strategy in people with Cervical Artery Dissection, run by University Department of Geriatric Medicine FELIX PLATTER.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Artery Dissection
- What is being tested?
- Antiplatelet Treatment Strategy and Anticoagulation Treatment Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
About this study
Official 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
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.
Read more
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.
- Conditions
- Cervical Artery Dissection
- Being tested
- Antiplatelet Treatment Strategy, Anticoagulation Treatment Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet Treatment StrategyProcedure or surgery
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 StrategyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet Treatment Strategy | Experimental | Not described Receives: Procedure: Antiplatelet Treatment Strategy |
| Anticoagulation Treatment Strategy | Experimental | Not described Receives: Procedure: Anticoagulation Treatment Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net effect of antiplatelet treatment strategy versus anticoagulation treatment strategy
The primary endpoint is a composite of the occurrence of (1) recurrent ischemic stroke, (2) major bleeding (extracranial or intracranial), or (3) vascular death
Measured: From enrollment to day 90 (± 2 weeks)
Secondary outcomes (6)
Occurrence of each single component of the primary composite outcome measure
Measured: From enrollment to day 90 (± 2 weeks)
- Functional neurological outcome (mRS)
absolute difference and shift in favorable outcome (defined as mRS ≤ 2)
Measured: From enrollment to day 90 (± 2 weeks)
All-cause mortality
Measured: From enrollment to day 90 (± 2 weeks)
Recurrence of Cervical Artery Dissection
Measured: From enrollment to day 90 (± 2 weeks)
Patient-reported outcome measure on global health (PROMIS-10)
Measured: From enrollment to day 90 (± 2 weeks)
Health related quality of life (EQ-5D Visual Analog scale)
Measured: From enrollment to day 90 (± 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Artery DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639892
- Sponsor's protocol ID
- 2026-01009
- Acronym
- TREAT-CAD 2
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07639892
- Acronym / sponsor ID
- TREAT-CAD 2 / 2026-01009
- Conditions
- Cervical Artery Dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTERUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet Treatment Strategy | Experimental | Procedure: Antiplatelet Treatment Strategy |
| Anticoagulation Treatment Strategy | Experimental | Procedure: Anticoagulation Treatment Strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 MRI with suitable sequences for CAD diagnosis
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiplatelet Treatment StrategyIncludes aspirin (ASA) or clopidogrel monotherapy or dual antiplatelet therapy (ASA + clopidogrel), at the choice of the treating physician but adhering to latest ESO guideline | Procedure or surgery | Antiplatelet Treatment Strategy |
| Anticoagulation Treatment StrategyIncludes 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 | Procedure or surgery | Anticoagulation Treatment Strategy |
Primary outcome
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
6 secondary outcomes
Occurrence of each single component of the primary composite outcome measure
Time frame: From enrollment to day 90 (± 2 weeks)
- Functional neurological outcome (mRS)
Time frame: From enrollment to day 90 (± 2 weeks)
All-cause mortality
Time frame: From enrollment to day 90 (± 2 weeks)
Recurrence of Cervical Artery Dissection
Time frame: 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)
Health related quality of life (EQ-5D Visual Analog scale)
Time frame: From enrollment to day 90 (± 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Antiplatelet Treatment Strategy and Anticoagulation Treatment Strategy in people with Cervical Artery Dissection, run by University Department of Geriatric Medicine FELIX PLATTER.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net effect of antiplatelet treatment strategy versus anticoagulation treatment strategy (time frame: From enrollment to day 90 (± 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.