The goal of this clinical randomised controlled trial is to compare two treatment strategies - antiplatelet treatment strategy versus anticoagulation treatment strategy - in patients with acute, ischemic Cervical Artery Dissection (CAD). The study population includes patients presenting with any (clinical or imaging) signs of cerebral ischemia due to CAD.
The trial aims to estimate the net effect of antiplatelet versus anticoagulation treatment strategies on the composite primary outcome including recurrent ischemic stroke, major bleeding, or vascular death at 90 days (±2 weeks) after randomization.
Participants will:
* be randomly allocated to antiplatelet treatment strategy or anticoagulation treatment strategy * receive treatment according to assigned strategy for the study period of 90 days * be followed up for 90 days (±2 weeks) after randomization * undergo clinical assessments to monitor for stroke recurrence, bleeding events, and vascular death Participant reported outcomes will be assessed both at 90 days (±2 weeks) and 12 months (± 4 weeks) after enrolment and will also expand to measures of quality of life and mental health outcomes.
Written informed consent (according to requirements by national legislation)
Onset/visualization of acute cerebral ischemia (≤ 3 days prior to randomization) attributable to CAD (either)
CLINICAL ISCHEMIA: onset of acute ischemic stroke (including retinal infarct) or transient ischemic attack (including amaurosis fugax) attributable to CAD OR
ISCHEMIA WITHOUT CORRESPONDING SYMPTOMS: visualization of acute ischemic lesion on diffusion weighted imaging attributable to CAD
Contraindications to either antiplatelets or oral anticoagulation therapy
Other indication than CAD for full dose oral anticoagulation
Contraindications for performance of MRI
Age < 18 years
Parallel
Antiplatelet Treatment Strategy
Procedure/SurgeryIncludes aspirin (ASA) or clopidogrel monotherapy or dual antiplatelet therapy (ASA + clopidogrel), at the choice of the treating physician but adhering to latest ESO guideline
Anticoagulation Treatment Strategy
Procedure/SurgeryIncludes vitamin K antagonists (phenprocoumon, acenocoumarol, warfarin) with target INR 2.0-3.0 and heparin/LMWH bridging if needed or DOACs (apixaban, edoxaban, dabigatran, rivaroxaban) - at the choice of the treating physician but adhering to latest ESO guideline
Net effect of antiplatelet treatment strategy versus anticoagulation treatment strategy
The primary endpoint is a composite of the occurrence of (1) recurrent ischemic stroke, (2) major bleeding (extracranial or intracranial), or (3) vascular death
Occurrence of each single component of the primary composite outcome measure
- Functional neurological outcome (mRS)
absolute difference and shift in favorable outcome (defined as mRS ≤ 2)
All-cause mortality
Recurrence of Cervical Artery Dissection
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
