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RE-SCORE: REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Completed
CT.gov ID
NCT03526614
Collaborator
(none)
480
Enrollment
1
Location
31
Actual Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    480 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    REpetitive Assessement of Thromboembolic and Bleeding SCOREs in Patients Treated With Dual Antiplatelet Therapy
    Actual Study Start Date :
    Jun 1, 2017
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Bleeding in the overall population [Up to 12 months]

      Bleeding episodes

    2. Bleeding in men and women [Up to 12 months]

      Bleeding episodes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Sapienza Rome Please Select Italy 00161

    Sponsors and Collaborators

    • University of Roma La Sapienza

    Investigators

    • Study Chair: Francesco Pelliccia, Sapienza University of Rome

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
    ClinicalTrials.gov Identifier:
    NCT03526614
    Other Study ID Numbers:
    • 2018/D/401
    First Posted:
    May 16, 2018
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 19, 2021