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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiplatelet Treatment Strategy | Experimental |
| |
| Anticoagulation Treatment Strategy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiplatelet Treatment Strategy | Procedure | Includes aspirin (ASA) or clopidogrel monotherapy or dual antiplatelet therapy (ASA + clopidogrel), at the choice of the treating physician but adhering to latest ESO guideline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to day 90 (± 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of each single component of the primary composite outcome measure | From enrollment to day 90 (± 2 weeks) | |
| - Functional neurological outcome (mRS) | absolute difference and shift in favorable outcome (defined as mRS ≤ 2) |
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Inclusion Criteria:
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 MRI with suitable sequences for CAD diagnosis
Diagnosis of Cervical Artery Dissection (i.e. extracranial carotid and/or vertebral artery) by MRI/A or CTA based on the presence of the following criteria (at least one)
Exclusion Criteria:
Thrombolysis and/or endovascular treatment (EVT) is/are not considered an exclusion criterion.
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Open label treatment - blinded endpoint assessor
| Anticoagulation Treatment Strategy | Procedure | Includes 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 |
|
| From enrollment to day 90 (± 2 weeks) |
| All-cause mortality | From enrollment to day 90 (± 2 weeks) |
| Recurrence of Cervical Artery Dissection | From enrollment to day 90 (± 2 weeks) |
| Patient-reported outcome measure on global health (PROMIS-10) | From enrollment to day 90 (± 2 weeks) |
| Health related quality of life (EQ-5D Visual Analog scale) | From enrollment to day 90 (± 2 weeks) |