Is therapy with anticoagulants better than treatment with antiplatelet agents for acute cervical artery dissection?
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen 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
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
Randomised, multi-centre, open treatment trial.
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.
|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|