Cardiovascular Diseases Clinical Trial
Official title:
A Randomized Study of Repetitive Assessement of PRECISE-DAPT Score During Dual Antiplatelet Therapy: The RE-SCORE Trial
Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet
therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to
assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine
clearance, haemoglobin, white blood- cell count and previous spontaneous bleeding. One should
consider, however, that some of the variables included in the PRECISE-DAPT score might change
with time. As a consequence, the PRECISE-DAPT score should not be considered a static score
as it might vary after the initial computation.
It remains unknown, however, if the use of the delta PRECISE-SCORE, which reflects the change
in score between baseline and follow-up, might help to improve the management of PCI patients
in order to decrease the bleeding risk during follow-up.
The RE-SCORE trial is a multicenter study aimed at comparing usual care of patients treated with PCI with a novel strategy of change of therapy during follow-up on the base of the Delta PRECISE-DAPT score, as assessed every 3 months in PCI patients receiving DAPT. The primary end-point of the study is the occurrence of bleeding, as defined according to the criteria of the Bleeding Academic Research Consortium (BARC). The second end-point is a composite of cardiac death, myocardial infarction, stroke, definite or probable stent thrombosis (ST), or BARC criteria type 2, 3 or 5 bleeding. ;
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