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

340/12

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.

2013-09-01

2019-06-01

2019-06-01

Completed

Early phase I

194

Inclusion Criteria: 1. Acute ischemic or non-ischemic symptoms within 2 weeks 2. Verification of CAD-diagnosis (carotid and/or vertebral) by MR-techniques (at least one): * mural hematoma or * pseudo-aneurysm or * long filiform stenosis or * intimal flap or * double lumen or * occlusion situated more than 2 cm above the bifurcation of the carotid artery, revealing a pseudo aneurysm or a long filiform stenosis after recanalisation. 3. Written informed consent by patient or next-to-kin 4. 24h latency period in case of thrombolysis 5. Age \> 18 years by time of inclusion Exclusion Criteria: 1. MR-contraindications (claustrophobia precluding MRI: patients agreeing to undergo MRI scanning with mild sedation may be entered into the study) 2. Contraindications to the use of anticoagulation (vitamin k antagonists, heparin) or ASA (according to the Swiss "Arzneimittelkompendium" http://www.compendium.ch/search/de or the "Rote Liste" (German centers) or "Lægemiddelstyrelsen - produktresume" for the Danish center (https://laegemiddelstyrelsen.dk/da/bivirkninger/find-medicin/produktresumeer/) and the judgment of the treating physician) 3. Pregnancy (Note: for women in child bearing age a pregnancy test has to be done prior to study entry)

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2024-05-21