Repetitive Assessement of PRECISE-DAPT Score (RE-SCORE)

March 26, 2020 updated by: Francesco Pelliccia, University of Roma La Sapienza

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00161
        • Sapienza University
      • Rome, Italy, 00100
        • San Raffaele Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive patients undergoing percutaneous coronary intervention
  • Indication to dual antiplatelet therapy for at least 3 months

Exclusion Criteria:

- Contraindications to dual antiplatelet therapy lasting more than 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual care
Patients will enter standard 12-month clinical follow-up
EXPERIMENTAL: Re-Score strategy
Patients will enter a novel strategy of 12-month follow with repetitive assessment of PRECISE-DAPT score at 3-month intervals
Diagnostic test: Repetitive assessment of PRECISE-DAPT score
The PRECISE-DAPT score, which takes into consideration age, creatinine clearance, haemoglobin, white blood-cell count and previous spontaneous bleeding, will be reassessed every 3 months during the 12-month follow-up period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding episode
Time Frame: 12 months
The time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic episode
Time Frame: 12 months
The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (ACTUAL)

February 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/D/101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe