REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy (RE-SCORE)
April 13, 2021 updated by: Francesco Pelliccia, University of Roma La Sapienza
REpetitive Assessement of Thromboembolic and Bleeding SCOREs in Patients Treated With 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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
480
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
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Please Select
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Rome, Please Select, Italy, 00161
- University Sapienza
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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
Sampling Method
Non-Probability Sample
Study Population
Patients with coronary artery disease and indication to PCI
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Bleeding in the overall population
Time Frame: Up to 12 months
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Bleeding episodes
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Up to 12 months
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Bleeding in men and women
Time Frame: Up to 12 months
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Bleeding episodes
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Up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Francesco Pelliccia, University of Roma La Sapienza
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
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
May 3, 2018
First Submitted That Met QC Criteria
May 15, 2018
First Posted (Actual)
May 16, 2018
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2018/D/401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.