NCT02046460: TREAT-CAD

Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection - TREAT-CAD

Completed Phase 3 Last updated 18 May 2024

What this trial tests

Phase 3 trial testing Acetylsalicylic acid in Cervical Artery Dissection in 194 participants. Completed in 1 June 2019.

Timeline

1 September 2013

Primary endpoint
1 June 2019

1 June 2019

Quick facts

Lead sponsor	Stefan Engelter
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	194
Start date	1 September 2013
Primary completion	1 June 2019
Estimated completion	1 June 2019
Sites	10 locations across Denmark, Germany, Switzerland

Drugs / interventions tested

• Acetylsalicylic acid (acetylsalicylic acid) — full drug profile →
• Vitamin K antagonist — full drug profile →

Conditions studied

• Cervical Artery Dissection — all drugs for Cervical Artery Dissection →

Sponsor

Stefan Engelter

Who can join

18 and older, any sex, with Cervical Artery Dissection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Primary composite outcome measure - labeled Cerebrovascular Ischemia, major Hemorrhagic events or Death (CIHD) -
  Time frame: 3 months
  CIHD - includes the following efficacy and safety outcome measures during the treatment period: includes the following efficacy and safety outcome measures during the treatment period: (i) occurrence of any stroke (including retinal infarction), new acute lesions on diffusion weighted MRI (ii) any major extracranial hemorrhage, any symptomatic intracranial hemorrhage and any asymptomatic micro- or

Sponsor's own description

Primary objective: To demonstrate the non-inferiority of acetylsalicylic acid (ASA) to anticoagulant treatment (vitamin K antagonists) in CAD-patients with regard to outcome and complication measures.

Methods: Randomized controlled, open labeled multicenter, non-inferiority trial with blinded assessment of outcome events.

Primary endpoint: Primary composite outcome measure - labeled Cerebrovascular Ischemia, major Hemorrhagic events or Death (CIHD) - includes the following efficacy and safety outcome measures during the treatment period: (i) occurrence of any stroke\*, new acute lesions on diffusion weighted MRI (ii) any major extracranial hemorrhage, any symptomatic intracranial hemorrhage and any asymptomatic micro- or macrobleeds, (iii) death.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. ESO guideline for the management of extracranial and intracranial artery dissection.
   Debette S, Mazighi M, Bijlenga P, Pezzini A, et al · · 2021 · cited 112× · PMID 34746432 · DOI 10.1177/23969873211046475
2. Aspirin versus anticoagulation in cervical artery dissection (TREAT-CAD): an open-label, randomised, non-inferiority trial.
   Engelter ST, Traenka C, Gensicke H, Schaedelin SA, et al · · 2021 · cited 101× · PMID 33765420 · DOI 10.1016/s1474-4422(21)00044-2
3. Biomarkers and antithrombotic treatment in cervical artery dissection - Design of the TREAT-CAD randomised trial.
   Traenka C, Gensicke H, Schaedelin S, Luft A, et al · · 2020 · cited 10× · PMID 33072885 · DOI 10.1177/2396987320921151
4. Toward Individual Treatment in Cervical Artery Dissection: Subgroup Analysis of the TREAT-CAD Randomized Trial.
   Kaufmann JE, Gensicke H, Schaedelin S, Luft AR, et al · · 2024 · cited 8× · PMID 38362818 · DOI 10.1002/ana.26886
5. The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection.
   Engelter ST, Enz LS, Ravanelli F, Kaufmann JE, et al · · 2025 · cited 3× · PMID 39910883 · DOI 10.1177/23969873251315362
6. ESOC 2023 – Late Breaking Abstracts
   · 2023 · cited 1×
7. ESOC 2023 Abstract Book
   · 2023