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

NCT02046460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2024-05-21

No results posted yet for this study

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

Interventions

DRUG

Acetylsalicylic acid

Acetylsalicylic acid, 300mg o.p.d.

DRUG

Vitamin K antagonist

Vitamin K-antagonists, target INR 2.0-3.0

Sponsors & Collaborators

  • Stefan Engelter

    lead OTHER

Principal Investigators

  • Stefan T. Engelter, MD · University Hospital, Neurorehab. Felix Platter, University of Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Denmark
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02046460 on ClinicalTrials.gov