MR CLEAN-MED - The Effect of Periprocedural Medication in Patients Undergoing Endovascular Treatment for Acute Ischemic Stroke: Heparin, Antiplatelet Agents, Both or Neither

Background: Rapid endovascular treatment (EVT) in patients with acute ischemic stroke with confirmed proximal intracranial occlusion has been proven safe and effective. Still, many patients do not recover despite recanalization. Yet, it is unknown whether periprocedural antithrombotic medication in patients treated with EVT can improve clinical outcome. The objective of this study is to assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin, alone, or in combination, in patients who undergo EVT. Methods: MR CLEAN-MED is a multicenter, prospective, randomized, open-label, blinded-endpoint trial using a 2x3 factorial design. We plan to enroll 1500 patients with a clinical diagnosis of acute ischemic stroke and confirmed intracranial anterior circulation occlusion, who will undergo EVT with or without prior intravenous thrombolysis according to standard care. Study interventions: IV treatment with ASA (300 mg), low dose unfractionated heparin (loading dose of 5000 IU followed by 500 IU/hour x 6 hours) and moderate dose unfractionated heparin (loading dose of 5000 IU followed by 1250 IU/hour x 6 hours). Primary outcome is the score on the modified Rankin Scale 90 days after inclusion in the study. Safety endpoints include the occurrence of symptomatic intracerebral hemorrhage. Results: First patient enrolled on January 22nd, 2018. 1 active enrolling site, 17 sites starting up. Conclusion: We hypothesize that despite the potentially increased risk of (symptomatic) intracerebral hemorrhage, periprocedural ASA and unfractionated heparin alone or in combination will improve functional outcome of patients with acute ischemic stroke treated with EVT. Trial Registration Number: ISRCTN 76741621 Funding: Dutch Heart Foundation, Dutch Brain Foundation, Stryker