Cervical Artery Dissection In Stroke Study: Feasibility Phase. "CADISS "

Recruiting

Phase N/A Results N/A

Trial Description

Is therapy with anticoagulants better than treatment with antiplatelet agents for acute cervical artery dissection?

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Dipyridamole (Persantine┬«)Drug
    Intervention Desc: Platelet aggregation inhibitor
  • Heparin (acute stroke) Drug
    Intervention Desc: Intravenous anticoagulant.
  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Anticoagulant (Vitamin K antagonist)
  • LMW heparin Drug
    Intervention Desc: Low molecular weight heparin and heparinoids. See also specific compounds, including danaparoid, dalteparin, enoxaparin, nadroparin, tinzaparin.
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic

Trial Design

Randomised, multi-centre, open treatment trial.

Patient Involvement

Patients will be randomised to either antiplatelet or anticoagulation therapy initially for at least 3 months, and thereafter at the discretion of the attending physician.

Arm 1: Antiplatelet therapy: Aspirin, dipyridamole or clopidogrel alone or in dual combination. Arm 2: Anticoagulation with heparin (intravenous adminsitration, either unfractionated heparin or a therapeutic dose of low molecularweight heparin) followed by warfarin administered orally aiming for an coagulant response time (INR) in the range 2-3. Local protocols for heparin therapy can be used.

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to first ipsilateral stroke or death (any cause) within 3 months from randomisation
Secondary The following will be measured at the 3-month follow up: 1. Ipsilateral TIA, stroke or death (any cause) within 3 months from randomisation 2. Any TIA and stroke 3. Any stroke 4. Major bleeding 5. Presence of residual stenosis at 3 months (>50%) 6. Mortality

Sponsors

St George's University of London (UK)