TREAT-CAD 2 Trial

Short description

TREAT-CAD 2 is a multicenter, prospective, randomized (1:1), open-label, blinded endpoint (PROBE) strategy trial, comparing two already established treatment strategies (antiplatelet versus anticoagulation treatment) for stroke prevention in patients with Cervical Artery Dissection (CAD). 1100 patients will be randomly assigned to either the antiplatelet or the anticoagulation treatment strategy arm with a ratio of 1:1 (550 patients per group). Patients will be randomly assigned to receive either mono- or dual antiplatelet therapy, or oral anticoagulation with vitamin K antagonists targeting an INR of 2.0–3.0, or direct oral anticoagulants administered at standard or reduced doses according to EMA/Swissmedic labeling and clinical criteria.

Both treatment strategies are consistent with current CAD ESO treatment guidelines, encompassing mono- or dual antiplatelet therapy as well as all forms of oral anticoagulation, including DOACs

Objective

The primary objective is to estimate the net effect of antiplatelet treatment strategy versus anticoagulation treatment strategy on the composite primary outcome including recurrent ischemic stroke, symptomatic bleeding, or vascular death at 90 days (± 2 weeks) after randomization in patients with acute ischemic CAD (i.e. patients presenting with any (clinical or imaging) signs of cerebral ischemia (including retinal ischemia) due to CAD).

Secondary objectives include to assess each single component of the composite primary outcome in the antiplatelet treatment strategy group compared to the anticoagulation treatment strategy group at 90 days (± 2 weeks) after randomization and to assess funcitonal neurological outcome (mRS), all-cause mortality and CAD recurrence in ischemic CAD patients at 90 days (± 2 weeks) after randomization and explore their association with antiplatelet versus anticoagulation treatment strategy.

Principle investigators