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.
January 15, 2019 - We congratulate the Erasmus MC University Medical Center of Rotterdam with the 100th inclusion.
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.
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