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

NCT02046460 | Completed Phase 3 DMC

• 1 other identifier: 340/12
• Study Type: interventional
• Target: 194
• Locations: 3 countries
• Sites: 10

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.

Conditions

Cervical Artery Dissection

Outcome Measures

Primary Outcomes (1)

• Primary composite outcome measure - labeled Cerebrovascular Ischemia, major Hemorrhagic events or Death (CIHD) -

  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.

  3 months

Secondary Outcomes (11)

• new ischemic strokes (including retinal infarction)

  3 months

• new acute lesions on diffusion-weighted MRI

  3 months

• any major extracranial hemorrhage

  3 months

• any symptomatic intracranial hemorrhage

  3 months

• any asymptomatic micro- or macrobleeds

  3 months

Study Arms (2)

Oral Anticoagulation

ACTIVE COMPARATOR

Vitamin K-Antagonists, target INR 2.0-3.0

Drug: Vitamin K antagonist

Antiplatelets

EXPERIMENTAL

Acetylsalicylic acid, 300mg o.p.d.

Drug: Acetylsalicylic acid

Interventions

Acetylsalicylic acid DRUG

Acetylsalicylic acid, 300mg o.p.d.

Also known as: ASA

Antiplatelets

Vitamin K antagonist DRUG

Vitamin K-antagonists, target INR 2.0-3.0

Also known as: Phenprocoumon, Warfarin, Acenocoumarol

Oral Anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic or non-ischemic symptoms within 2 weeks
• 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
• h latency period in case of thrombolysis

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stefan Engelter: lead

Study Sites (10)

University Hospital, Stroke Center Bispebjerg Hospital Copenhagen, Denmark

Copenhagen, Denmark

Location

University Hospital, Stroke Center Charite Berlin, Germany

Berlin, Germany

Location

University Hospital, Stroke Center LMU Munich, Germany

Munich, Germany

Location

Kantonsspital, Stroke Center Aarau, Switzerland

Aarau, Switzerland

Location

University Hospital, Stroke Center Basel, Switzerland

Basel, Switzerland

Location

University Hospital, Stroke Center Inselspital Berne, Switzerland

Bern, Switzerland

Location

University Hospital, Stroke Center Geneva, Switzerland

Geneva, Switzerland

Location

University Hospital, Stroke Center CHUV Lausanne, Switzerland

Lausanne, Switzerland

Location

Kantonsspital, Stroke Center St. Gallen, Switzerland

Sankt Gallen, Switzerland

Location

University Hospital, Stroke Center Zurich, Switzerland

Zurich, Switzerland

Location

Related Publications (3)

• Traenka C, Gensicke H, Schaedelin S, Luft A, Arnold M, Michel P, Kagi G, Kahles T, Nolte CH, Kellert L, Rosenbaum S, Sztaizel R, Brehm A, Stippich C, Psychogios M, Lyrer P, Engelter ST; TREAT-CAD investigators. Biomarkers and antithrombotic treatment in cervical artery dissection - Design of the TREAT-CAD randomised trial. Eur Stroke J. 2020 Sep;5(3):309-319. doi: 10.1177/2396987320921151. Epub 2020 Jun 29.

  PMID: 33072885 BACKGROUND

• Engelter ST, Traenka C, Gensicke H, Schaedelin SA, Luft AR, Simonetti BG, Fischer U, Michel P, Sirimarco G, Kagi G, Vehoff J, Nedeltchev K, Kahles T, Kellert L, Rosenbaum S, von Rennenberg R, Sztajzel R, Leib SL, Jung S, Gralla J, Bruni N, Seiffge D, Feil K, Polymeris AA, Steiner L, Hamann J, Bonati LH, Brehm A, De Marchis GM, Peters N, Stippich C, Nolte CH, Christensen H, Wegener S, Psychogios MN, Arnold M, Lyrer P; TREAT-CAD investigators. Aspirin versus anticoagulation in cervical artery dissection (TREAT-CAD): an open-label, randomised, non-inferiority trial. Lancet Neurol. 2021 May;20(5):341-350. doi: 10.1016/S1474-4422(21)00044-2. Epub 2021 Mar 23.

  PMID: 33765420 BACKGROUND

• Engelter ST, Enz LS, Ravanelli F, Kaufmann JE, Gensicke H, Schaedelin S, Luft AR, Globas C, Goeggel-Simonetti B, Fischer U, Strambo D, Kagi G, Nedeltchev K, Kahles T, Kellert L, Rosenbaum S, von Rennenberg R, Brehm A, Seiffge D, Renaud S, Brandt T, Sarikaya H, Zietz A, Wischmann J, Polymeris AA, Fischer S, Bonati LH, De Marchis GM, Peters N, Nolte CH, Christensen H, Wegener S, Psychogios MN, Arnold M, Lyrer P, Traenka C. The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection. Eur Stroke J. 2025 Sep;10(3):871-881. doi: 10.1177/23969873251315362. Epub 2025 Feb 5.

  PMID: 39910883 DERIVED

MeSH Terms

Interventions

Aspirin; acarboxyprothrombin; Phenprocoumon; Warfarin; Acenocoumarol

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stefan T. Engelter, MD

  University Hospital, Neurorehab. Felix Platter, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: PROBE-Design: Prospective, randomized, open-label, blinded assessment of end-points.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med., MD

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: September 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

DK (1); DE (2); CH (7)