Repetitive Assessement of PRECISE-DAPT Score
RE-SCORE
A Randomized Study of Repetitive Assessement of PRECISE-DAPT Score During Dual Antiplatelet Therapy: The RE-SCORE Trial
1 other identifier
interventional
500
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Jun 2017
Typical duration for not_applicable cardiovascular-diseases
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 30, 2020
March 1, 2020
2.6 years
February 19, 2019
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding episode
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 Outcomes (1)
Ischemic episode
12 months
Study Arms (2)
Usual care
NO INTERVENTIONPatients will enter standard 12-month clinical follow-up
Re-Score strategy
EXPERIMENTALPatients will enter a novel strategy of 12-month follow with repetitive assessment of PRECISE-DAPT score at 3-month intervals
Interventions
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
Eligibility Criteria
You may qualify if:
- Consecutive patients undergoing percutaneous coronary intervention
- Indication to dual antiplatelet therapy for at least 3 months
You may not qualify if:
- \- Contraindications to dual antiplatelet therapy lasting more than 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Raffaele Pisana
Rome, 00100, Italy
Sapienza University
Rome, 00161, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carlo Gaudio, MD
Sapienza University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 20, 2019
Study Start
June 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share