Biomarkers and antithrombotic treatment in cervical artery dissection - Design of the TREAT-CAD randomised trial.

Traenka, Christopher; Gensicke, Henrik; Schaedelin, Sabine; Luft, Andreas; Arnold, Marcel; Michel, Patrik; Kägi, Georg; Kahles, Timo; Nolte, Christian H; Kellert, Lars; Rosenbaum, Sverre; Sztaizel, Roman; Brehm, Alex; Stippich, Christoph; Psychogios, Marios; Lyrer, Philippe; Engelter, Stefan T (2020). Biomarkers and antithrombotic treatment in cervical artery dissection - Design of the TREAT-CAD randomised trial. European stroke journal, 5(3), pp. 309-319. Sage 10.1177/2396987320921151

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Introduction

The type of antithrombotic treatment in cervical artery dissection patients is still a matter of debate. Most physicians prefer anticoagulants over antiplatelet agents for stroke prevention. However, this approach is not evidence-based and antiplatelets might be as safe and as effective. The 'Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection' ('TREAT-CAD') trial (clinicaltrials.gov: NCT02046460) compares Aspirin to oral anticoagulants (vitamin K antagonists) with regard to efficacy and safety by using both clinical and imaging surrogate outcome measures. TREAT-CAD tests the hypothesis, that aspirin is as safe and effective as vitamin K antagonists.

Patients and methods

TREAD-CAD is a Prospective, Randomised controlled, Open-labelled, multicentre, non-inferiority trial with Blinded assessment of outcome Events (PROBE-design). Key eligibility criteria are (i) clinical symptoms attributable to cervical artery dissection and (ii) verification of the cervical artery dissection diagnosis by established magnetic resonance imaging criteria. Patients are randomised to receive either Aspirin 300 mg daily or vitamin K antagonists for 90 days.

Results

Primary outcomes are assessed at 14 ± 10 days (magnetic resonance imaging and clinical examination) and at 90 ± 30 days (clinical examinations). The primary endpoint is a composite outcome measure - labelled Cerebrovascular Ischemia, major Hemorrhagic events or Death (CIHD) - and includes (i) occurrence of any stroke (including retinal infarction), (ii) new ischaemic lesions on diffusion-weighted magnetic resonance imaging, (iii) any major extracranial haemorrhage, (iv) any symptomatic intracranial haemorrhage, (v) any new haemorrhagic lesion visible on paramagnetic-susceptible sequences and (vi) death.

Discussion

After database closure, (i) central verification of cervical artery dissection diagnosis will be done by two experienced raters, (ii) adjudication of outcome events will be performed by independent adjudication committees, separately for clinical and imaging outcomes. The primary analysis will be done on the per protocol data set. The targeted sample size consists of 169 evaluable patients in the per protocol data set.

Conclusion

TREAT-CAD is testing the non-inferiority of Aspirin versus vitamin K antagonists treatment in patients with symptomatic cervical artery dissection by combined clinical and magnetic resonance imaging outcomes.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Arnold, Marcel

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2396-9873

Publisher:

Sage

Language:

English

Submitter:

Chantal Kottler

Date Deposited:

10 Nov 2020 15:46

Last Modified:

10 Nov 2020 15:46

Publisher DOI:

10.1177/2396987320921151

PubMed ID:

33072885

Uncontrolled Keywords:

Cervical artery dissection anticoagulants antiplatelets prevention randomised clinical trial stroke

BORIS DOI:

10.7892/boris.147369

URI:

https://boris.unibe.ch/id/eprint/147369

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