NCT03526614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

May 3, 2018

Last Update Submit

April 13, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Bleeding in the overall population

    Bleeding episodes

    Up to 12 months

  • Bleeding in men and women

    Bleeding episodes

    Up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary artery disease and indication to PCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Sapienza

Rome, Please Select, 00161, Italy

Location

Related Publications (2)

  • 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 Officials

  • Francesco Pelliccia

    University of Roma La Sapienza

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

June 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations