NCT03526614

REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

REpetitive Assessement of Thromboembolic and Bleeding SCOREs in Patients Treated With Dual Antiplatelet Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 480 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 delta PRECISE-SCORE, reflecting the change in score between baseline and follow-up, might predict more reliably the long-term bleeding risk of PCI patients.

Detailed description

The RE-SCORE registry is a multicenter study aimed at comparing the predictive value of the PRECISE-DAPT score assessed at time of discharge vs. 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), either in the whole study population or in men vs women.

Conditions

• Dual Anti-platelet Therapy

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-05-16
• Last updated: 2021-04-19

Locations

1 site across 1 country: Italy