DSMB report of 2nd interim analysis and 11th safety assesment
The DSMB advised that the Trial Steering Committee (TSC) should be unblinded to the outcome data (all treatment groups) in order to make a decision about stopping or continuing one or both of the remaining arms of the trial. We decided to follow the advice of the DSMB. After analyses of the DSMB report the TSC decided to stop inclusion of patients into the trial. We will use the upcoming months to complete our database, after which we will report our final results.
10th safety report
November 11, 2020 – DSMB report of 10th safety assessment: no safety concerns. The recommendation is therefore to continue the trial as planned.
Publication - Trial protocol
July, 2020 - the MR CLEAN MED trial protocol has been accepted for publication in trials and can be found here.
July, 2020 - Please find here our presentation held during ECR 2020
June, 2019 - Our paper on periprocedural heparin use among dutch intervention centers in the MR CLEAN Registry has been accepted for publication and can be found here.
Click here for the PDF version.
June, 2019 - First patient included in Rijnstate hospital, Arnhem.
ESOC Milan 2019
May, 2019 - The progress of the MR CLEAN MED trial was presented as a poster during this year’s ESOC, by trial coordinators R.A. van de Graaf and B. Roozenbeek. We were pleased to discuss the challenges and achievements of the trial so far.
May, 2019 - First patient included in HagaZiekenhuis, Den Haag.
April 16, 2019 - Following on receipt of the 4th Safety Report from the MR CLEAN MED trial, the DSMB recommended unanimously that the Steering Committee should consider stopping the moderate-dose heparin arm of the trial, but should continue the other arms of the trial. The grounds for stopping related to safety rather than efficacy.
The executive committee of the trial has acted upon receiving this advice, and directly stopped inclusion in this part of the trial. No patients have been included in the moderate-dose heparin arm after receipt of the DSMB recommendation.
After consulting the Medical Ethics committee, and with approval of the Steering committee, the inclusion of patients in the ASA and low dose heparin arms are continued.
Meanwhile, patients, family and representatives have been contacted personally and regulatory bodies have been notified.
April, 2019 - First patient included in Radboud University Medical Center, Nijmegen.
ISC Honolulu 2019
February, 2019 - The progress of the MR CLEAN MED trial was presented as a poster.
January 15, 2019 - We congratulate the Erasmus MC University Medical Center of Rotterdam with the 100th inclusion.
January, 2019 -First patient included in Maastricht University Medical Center, Maastricht .
Third safety report
December 24, 2018 - Third safety report to DSMB: no safety concerns.
Second safety report
December 4, 2018 - Second safety report to DSMB: no safety concerns.
October, 2018 - First patient included in Amsterdam University Medical Center, location AMC.
First safety report
August 3, 2018 - First safety report to DSMB: no safety concerns.
Review on periprocedural antithrombotic use
April 16, 2018 - Our systematic review on periprocedural antithrombotic use is accepted for publication in “Frontiers in Neurology” stating the necessity of a randomized clinical trial. https://doi.org/10.3389/fneur.2018.00238
Jan 22, 2018 - First patient included in the trial in the Erasmus MC, Rotterdam
Dec 06, 2017 - We are registered under ISRCTN76741621