Closed trials
MR CLEAN MED
MR CLEAN-MED is a Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands investigating the effect of periprocedural MEDication: heparin, antiplatelet agents, both or neither. This trial is designed to answer the question if periprocedural administration of antithrombotic drugs can further improve the beneficial effect of acute endovascular thrombectomy for ischemic stroke.
Final patient included in the MR CLEAN MED
Between January 22th, 2018, and January 27th, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-treat population. On Feb 4, 2021, after unblinding and analysis of the data, the trial steering committee permanently stopped patient recruitment and the trial was stopped for safety concerns.
Results of the MR CLEAN-MED trial have been published in the Lancet in March 2022: https://www.sciencedirect.com/science/article/pii/S0140673622000149?via%3Dihub
Kind regards,
MR CLEAN-MED executive committee on behalf of the CONTRAST consortium:
Diederik Dippel, Aad van der Lugt, Rob van de Graaf, Bob Roozenbeek, Adriaan van Es, Heleen den Hertog, Julie Staals, Sjoerd Jenniskens, Lukas van Dijk
MR CLEAN MED Rationale and aim
Despite the successful results of acute mechanical thrombectomy in ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation , still a considerable proportion of patients does not recover. This may to a large extent be explained by incomplete microvascular reperfusion (IMR). IMR has been linked to distal microvascular damage or dysfunction as a result of tissue necrosis and cell death (due to late intervention), but also to distal microvascular occlusion caused by pericyte contraction, microtrombi or cellular plugs. This IMR can possibly be restored by pharmacologic management. We hypothesize that periprocedural antithrombotic treatment improves microvascular reperfusion in patients with ischemic stroke undergoing acute mechanical thrombectomy, but whether it improves clinical outcome is unknown.
The purpose of MR CLEAN-MED is to answer the question whether intravenous treatment with acetylsalicylic acid, unfractionated heparin, both or neither, during mechanical thrombectomy is beneficial and leads to better outcomes than the current strategy, which is to postpone this treatment to at least 24 hours after intervention.
MR CLEAN MED Study design
MR CLEAN-MED is a multicenter phase III randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE), with a 2×2 factorial design. The study will run for 4 years in stroke intervention centers in the Netherlands.
Intervention (2×2 factorial design):
Acetylsalicylic acid (ASA):
- No administration of ASA.
- Treatment with intravenous ASA 300 mg.
Unfractionated heparin (UFH):
- No administration of UFH.
- Low dose intravenous UFH: Loading dose of 5000 IU, followed by continuous infusion of 500 IU/hour over 6 hours.
MR CLEAN MED Organization
Principal investigators:
Diederik W.J. Dippel, neurologist, Erasmus MC, Rotterdam
Aad van der Lugt, neuroradiologist, Erasmus MC, Rotterdam
Coordinating investigators:
Rob A. van de Graaf, PhD-student, Erasmus MC, Rotterdam
Wouter van der Steen, PhD-student, Erasmus MC, Rotterdam
Bob Roozenbeek, neurologist, Erasmus MC, Rotterdam
Executive committee:
Rob A. van de Graaf, PhD-student, Erasmus MC, Rotterdam
Bob Roozenbeek, neurologist, Erasmus MC, Rotterdam
Diederik W.J. Dippel, neurologist, Erasmus MC, Rotterdam
Aad van der Lugt, neuroradiologist, Erasmus MC, Rotterdam
Adriaan C.G.M. van Es, neurointerventionist, Erasmus MC, Rotterdam
Heleen M. den Hertog , neurologist, Medisch Spectrum Twente, Enschede
Julie Staals, neurologist, Maastricht UMC, Maastricht
Lukas C. van Dijk, radiologist, Hagaziekenhuis, Den Haag
Sjoerd F. Jenniskens, radiologist, Radboud UMC, Nijmegen
MR CLEAN MED Progress of the trial
