drugset / Trial / NCT02046460

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

NCT02046460

Phase 3 Completed 194 enrolled Stefan Engelter
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 300 mg Oral
Comparator Phenprocoumon Small molecule Oral
Comparator Warfarin Small molecule Oral
Comparator acenocoumarol Unknown Oral