Skip to main content
OpenTrials
Completed

NCT Number: NCT03526614

REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dual Anti-Platelet Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Sapienza

Rome, Please Select, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bleeding in the overall population

    Time frame: Up to 12 months

    Bleeding episodes

  2. Bleeding in men and women

    Time frame: Up to 12 months

    Bleeding episodes

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: RE-SCORE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.