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

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ClinicalTrials.gov Identifier: NCT02046460
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Stefan Engelter, University Hospital, Basel, Switzerland

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cervical Artery Dissection Drug: Acetylsalicylic acid Drug: Vitamin K antagonist Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: PROBE-Design: Prospective, randomized, open-label, blinded assessment of end-points.
Primary Purpose: Treatment
Official Title: Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection - TREAT-CAD
Study Start Date : September 2013
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Oral Anticoagulation
Vitamin K-Antagonists, target INR 2.0-3.0
 Drug: Vitamin K antagonist
Vitamin K-antagonists, target INR 2.0-3.0
Other Name: Phenprocoumon, Warfarin, Acenocoumarol
Experimental: Antiplatelets
Acetylsalicylic acid, 300mg o.p.d.
 Drug: Acetylsalicylic acid
Acetylsalicylic acid, 300mg o.p.d.
Other Name: ASA


Outcome Measures
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Primary Outcome Measures :
  1. Primary composite outcome measure - labeled 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: includes the following efficacy and safety outcome measures during the treatment period: (i) occurrence of any stroke (including retinal infarction), new acute lesions on diffusion weighted MRI (ii) any major extracranial hemorrhage, any symptomatic intracranial hemorrhage and any asymptomatic micro- or macrobleeds, (iii) death.


Secondary Outcome Measures :
  1. new ischemic strokes (including retinal infarction) [ Time Frame: 3 months ]
  2. new acute lesions on diffusion-weighted MRI [ Time Frame: 3 months ]
  3. any major extracranial hemorrhage [ Time Frame: 3 months ]
  4. any symptomatic intracranial hemorrhage [ Time Frame: 3 months ]
  5. any asymptomatic micro- or macrobleeds [ Time Frame: 3 months ]
  6. any death [ Time Frame: 3 months ]
  7. any increase in volume of the vessel wall hematoma at the followup cervical MRI as compared to the baseline MR-scan [ Time Frame: 3 months ]
  8. independence in activity of daily living (modified Rankin scale 0-2) at 3 months and at 6 months [ Time Frame: 3 months ]
  9. excellent functional outcome (modified Rankin scale 0,1) at 3 month and at 6 months [ Time Frame: 3 months ]
  10. any TIA (classical definition) [ Time Frame: 3 months ]
  11. recurrent cervical artery dissection [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046460


Locations
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Denmark
University Hospital, Stroke Center Bispebjerg Hospital Copenhagen, Denmark
Copenhagen, Denmark
Germany
University Hospital, Stroke Center Charite Berlin, Germany
Berlin, Germany
University Hospital, Stroke Center LMU Munich, Germany
Munich, Germany
Switzerland
Kantonsspital, Stroke Center Aarau, Switzerland
Aarau, Switzerland
University Hospital, Stroke Center Basel, Switzerland
Basel, Switzerland
University Hospital, Stroke Center Inselspital Berne, Switzerland
Berne, Switzerland
University Hospital, Stroke Center Geneva, Switzerland
Geneva, Switzerland
University Hospital, Stroke Center CHUV Lausanne, Switzerland
Lausanne, Switzerland
Kantonsspital, Stroke Center St. Gallen, Switzerland
St. Gallen, Switzerland
University Hospital, Stroke Center Zurich, Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Stefan Engelter
Investigators
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Principal Investigator: Stefan T. Engelter, MD University Hospital, Neurorehab. Felix Platter, University of Basel, Switzerland
  Study Documents (Full-Text)

Documents provided by Stefan Engelter, University Hospital, Basel, Switzerland:
Statistical Analysis Plan  [PDF] December 18, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stefan Engelter, Prof. Dr. med., MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02046460    
Other Study ID Numbers: 340/12
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aspirin
Vitamin K
Warfarin
Acenocoumarol
Phenprocoumon
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Antifibrinolytic Agents