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

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stefan Engelter; University Hospital, Basel, Switzerland
• Collaborators: University Hospital Inselspital, Berne; University of Lausanne Hospitals
• Treatments: Acenocoumarol; Aspirin; Phenprocoumon; Vitamin K; Vitamins; Warfarin

Criteria

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)