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
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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 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Oral Anticoagulation
Vitamin K-Antagonists, target INR 2.0-3.0
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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.
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Drug: Acetylsalicylic acid
Acetylsalicylic acid, 300mg o.p.d.
Other Name: ASA |
- 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.
- new ischemic strokes (including retinal infarction) [ Time Frame: 3 months ]
- new acute lesions on diffusion-weighted MRI [ Time Frame: 3 months ]
- any major extracranial hemorrhage [ Time Frame: 3 months ]
- any symptomatic intracranial hemorrhage [ Time Frame: 3 months ]
- any asymptomatic micro- or macrobleeds [ Time Frame: 3 months ]
- any death [ Time Frame: 3 months ]
- 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 ]
- independence in activity of daily living (modified Rankin scale 0-2) at 3 months and at 6 months [ Time Frame: 3 months ]
- excellent functional outcome (modified Rankin scale 0,1) at 3 month and at 6 months [ Time Frame: 3 months ]
- any TIA (classical definition) [ Time Frame: 3 months ]
- recurrent cervical artery dissection [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute ischemic or non-ischemic symptoms within 2 weeks
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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.
- Written informed consent by patient or next-to-kin
- 24h latency period in case of thrombolysis
- Age > 18 years by time of inclusion
Exclusion Criteria:
- MR-contraindications (claustrophobia precluding MRI: patients agreeing to undergo MRI scanning with mild sedation may be entered into the study)
- 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)
- Pregnancy (Note: for women in child bearing age a pregnancy test has to be done prior to study entry)

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
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 |
Principal Investigator: | Stefan T. Engelter, MD | University Hospital, Neurorehab. Felix Platter, University of Basel, Switzerland |
Documents provided by Stefan Engelter, University Hospital, Basel, Switzerland:
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 |
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 |