REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

NCT ID: NCT03526614

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Dual Anti-platelet Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Pelliccia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Pelliccia

Role: STUDY_CHAIR

University of Roma La Sapienza

Locations

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University Sapienza

Rome, Please Select, Italy

Site Status

Countries

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Italy

References

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Pelliccia F, Gragnano F, Pasceri V, Marazzi G, Cacciotti L, Placanica A, Niccoli G, Palmerini T, Speciale G, Granatelli A, Calabro P. Gender-related differences in changes of estimated bleeding risk in patients on dual antiplatelet therapy: the RE-SCORE multicenter prospective registry. Platelets. 2022 Nov 17;33(8):1228-1236. doi: 10.1080/09537104.2022.2102602. Epub 2022 Jul 25.

Reference Type DERIVED
PMID: 35875853 (View on PubMed)

Pelliccia F, Pasceri V, Marazzi G, Cacciotti L, Placanica A, Gragnano F, Niccoli G, Palmerini T, Tanzilli G, Speciale G, Granatelli A, Calabro P, Crea F, Gaudio C. Predictive ability of longitudinal changes in PRECISE-DAPT score in patients on dual antiplatelet therapy: The RE-SCORE multicentre prospective registry. Eur J Prev Cardiol. 2021 Oct 13;28(12):e36-e38. doi: 10.1177/2047487320937846. Epub 2020 Jul 5. No abstract available.

Reference Type DERIVED
PMID: 34647586 (View on PubMed)

Other Identifiers

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2018/D/401

Identifier Type: -

Identifier Source: org_study_id

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