Antithrombotic Treatment Strategies in Cervical Artery Dissection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Department of Geriatric Medicine FELIX PLATTER

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Antiplatelet Treatment Strategy
  • Anticoagulation Treatment Strategy

Treatment groups

1,100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations