REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

Dual Anti-platelet Therapy Clinical Trial

— RE-SCORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526614
• Other study ID #: 2018/D/401
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: All patients undergoing percutaneous coronary intervention and treated with dual antiplatelet therapy for at least 3 months

Exclusion Criteria: Contraindications to dual antiplatelet therapy lasting more than 3 months

Related Conditions & MeSH terms

• Dual Anti-platelet Therapy

Locations

Country	Name	City	State
Italy	University Sapienza	Rome	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding in the overall population	Bleeding episodes	Up to 12 months
Primary	Bleeding in men and women	Bleeding episodes	Up to 12 months