Clinical Trial: Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection - TREAT-CAD

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection - TREAT-CAD

Brief Summary: The primary objective is to demonstrate the non-inferiority of treatment with ASA to anti-coagulant treatment with vitamin K antagonists in patients after a cervical artery dissection (CAD).

Detailed Summary:

This is a randomized controlled, open labeled multicenter, non-inferiority trial with blinded assessment of outcome events. Implementation of this study is planned at Swiss Stroke Centers or Units.

Identical investigations will be performed in all patients eligible to participate in this study.

Imaging: For verification of CAD diagnosis, all study participants will undergo a standardized routine MRI scan of brain and neck before study entry. 14 +/- 7 days after treatment onset a second MRI of brain and neck will be performed. The following MRI sequences will be performed on a 3 Tesla scanner (1) spin echo (SE) T1w, turbo spin-echo (TSE) T2w, FLAIR to detect chronic ischemic brain lesions. (2) Diffusion weighted imaging (DWI) including apparent diffusion coefficient (ADC) maps to detect acute ischemic brain lesions. (3) susceptibility-weighted imaging (SWI) sequences or T2*w gradient echo (GRE) to detect hemorrhagic brain lesions (4) contrast-enhanced magnetic resonance angiography (CE-MRA) to improve delineation of the wall hematoma against the perfused vessel lumen, and to assess the degree of obstruction of the affected artery. MRI scans will be centrally analysed at the University Hospital Basel, and independently assessed by two observers who are blinded to the type of treatment and clinical outcome.

Clinical examination: Patients will be examined clinically by a neurologist at the screening visit, at the randomization visit, 14 +/- 7 days after randomization, at 3 months and at 6 months after randomization. At each visit, clinical outcome events will be assessed, focal neurological deficit measured using the National Institutes of Health (NIH) Stroke Scale,12 and functional level of independence using the modified Rankin Scale13. Clinical outcome events will be indepen
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: Cerebrovascular Ischemia, major Hemorrhagic events or Death (CIHD) [ Time Frame: 3 months ]

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 macro bleeds, (iii) death.


Original Primary Outcome: occurrence of any stroke [ Time Frame: 3 months ]

Current Secondary Outcome:

  • New ischemic strokes; any symptomatic intracranial bleeds; any asymptomatic bleeds; any death; any increase in vessel wall hematoma; magnetic resonance spectroscopy (mRS) 0-2; mRS 0-1; any transient ischemic attack (TIA) [ Time Frame: 3 months ]
  • new acute DWI lesions [ Time Frame: 3 months ]
  • any major extracranial bleeds [ Time Frame: 3 months ]


Original Secondary Outcome: new ischaemic stroke [ Time Frame: 3 months ]

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: January 23, 2014
Date Started: September 2013
Date Completion: December 2018
Last Updated: December 12, 2016
Last Verified: December 2016