Following the COMPLETEstudy, we decided to pause the randomization in the FULL REVASC study (September 11, 2019). To decide how to move forward with the study, we analyzed some preliminary and unadjudicated data, and our statistician presented new power calculations based on the current 1,545 patients. This data was sent to the Steering Committee and to the DSMB for discussion. Based on their discussions and recommendations, the study sponsor Karolinska University Hospital decided to change the study according to the mutual proposal.
In summary:
- To definitely close inclusion of more patients into the study.
- To change the primary endpoint to the triple composite of death, MI or unplanned revascularization.
- To continue follow-up for all patients for 24-36 months after last patient in. The cut-off date being decided after a better estimate of event rates is available, when more patients have had their 1-year visit and event adjudication is under way.
We are now updating the protocol accordingly and we will send you the amended protocol as soon we have formal ethical approval for the changes made.
If you have any questions or concerns regarding this, please do not hesitate to contact us!