Background and Aims
Several trials have shown that endovascular treatment (EVT) following intravenous alteplase (IVT) improves outcome of patients with acute ischemic stroke and a proximal intracranial occlusion. A recent meta-analysis of five randomized trials (Hermes collaboration, Lancet 2016), which also included patients with contraindications for IVT, showed that the effect of EVT is not influenced by IVT. The question arises whether IVT is beneficial in patients eligible for EVT.

Method
The MR CLEAN-NO IV trial is a multicenter, prospective, randomized, open-label, blinded-endpoint trial, comparing IVT followed by EVT with direct EVT in patients with a confirmed occlusion of the distal intracranial carotid artery, M1 or proximal M2. We aim to include 540 patients. The primary endpoint is the modified Rankin Scale score (mRs) at 90 days. Secondary endpoints include eTICI score, and Barthel score at 90 days.  Safety endpoints include symptomatic intracranial hemorrhage and embolization in a new territory on angiography during EVT.

The primary effect parameter is the common odds ratio of the mRs, estimated by ordinal logistic regression. We will adjust for age, pre-stroke mRs, time from onset to randomization, stroke severity and collateral score. We will perform subgroup analyses for occlusion location, collateral score and thrombus perviousness, among others.

Results
Currently recruiting patients.

Conclusion
The MR CLEAN NO-IV trial will provide robust data on whether IVT is beneficial to patients who are eligible for EVT and who present to a comprehensive stroke center


Trial Registration number: ISRCTN80619088

MR CLEAN-NO IV: INTRAVENOUS TREATMENT FOLLOWED BY ENDOVASCULAR TREATMENT VERSUS DIRECT ENDOVASCULAR TREATMENT FOR ACUTE ISCHEMIC STROKE CAUSED BY A PROXIMAL INTRACRANIAL OCCLUSION