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

Summary

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.

Timeline

Start

2013-09

Primary completion

2019-06

Completion

2019-06

Outcome

Missed primary endpoint

paper TREAT-CAD could not establish non-inferiority of aspirin to anticoagulation at 3 months. PMID 39910883 ↗

Publications

• Background Traenka C, Gensicke H, Schaedelin S, Luft A, Arnold M, Michel P, Kagi G, Kahles T, Nolte CH, Kellert L, Rosenbaum S, Sztaizel R, Brehm A, Stippich C, Psychogios M, Lyrer P, Engelter ST; TREAT-CAD investigators. Biomarkers and antithrombotic treatment in cervical artery dissection - Design of the TREAT-CAD randomised trial. Eur Stroke J. 2020 Sep;5(3):309-319. doi: 10.1177/2396987320921151. Epub 2020 Jun 29.
• Background Engelter ST, Traenka C, Gensicke H, Schaedelin SA, Luft AR, Simonetti BG, Fischer U, Michel P, Sirimarco G, Kagi G, Vehoff J, Nedeltchev K, Kahles T, Kellert L, Rosenbaum S, von Rennenberg R, Sztajzel R, Leib SL, Jung S, Gralla J, Bruni N, Seiffge D, Feil K, Polymeris AA, Steiner L, Hamann J, Bonati LH, Brehm A, De Marchis GM, Peters N, Stippich C, Nolte CH, Christensen H, Wegener S, Psychogios MN, Arnold M, Lyrer P; TREAT-CAD investigators. Aspirin versus anticoagulation in cervical artery dissection (TREAT-CAD): an open-label, randomised, non-inferiority trial. Lancet Neurol. 2021 May;20(5):341-350. doi: 10.1016/S1474-4422(21)00044-2. Epub 2021 Mar 23.
• Engelter ST, Enz LS, Ravanelli F, Kaufmann JE, Gensicke H, Schaedelin S, Luft AR, Globas C, Goeggel-Simonetti B, Fischer U, Strambo D, Kagi G, Nedeltchev K, Kahles T, Kellert L, Rosenbaum S, von Rennenberg R, Brehm A, Seiffge D, Renaud S, Brandt T, Sarikaya H, Zietz A, Wischmann J, Polymeris AA, Fischer S, Bonati LH, De Marchis GM, Peters N, Nolte CH, Christensen H, Wegener S, Psychogios MN, Arnold M, Lyrer P, Traenka C. The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection. Eur Stroke J. 2025 Sep;10(3):871-881. doi: 10.1177/23969873251315362. Epub 2025 Feb 5.

Drugs

Indications