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Repetitive Assessement of PRECISE-DAPT Score (RE-SCORE)

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ClinicalTrials.gov Identifier: NCT03848572
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Interventional Cardiology Diagnostic Test: Repetitive assessment of PRECISE-DAPT score Not Applicable

Detailed Description:
The RE-SCORE trial is a multicenter study aimed at comparing usual care of patients treated with PCI with a novel strategy of change of therapy during follow-up on the base of 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). The second end-point is a composite of cardiac death, myocardial infarction, stroke, definite or probable stent thrombosis (ST), or BARC criteria type 2, 3 or 5 bleeding.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Study of Repetitive Assessement of PRECISE-DAPT Score During Dual Antiplatelet Therapy: The RE-SCORE Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
No Intervention: Usual care
Patients will enter standard 12-month clinical follow-up
Experimental: Re-Score strategy
Patients will enter a novel strategy of 12-month follow with repetitive assessment of PRECISE-DAPT score at 3-month intervals
Diagnostic Test: Repetitive assessment of PRECISE-DAPT score
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




Primary Outcome Measures :
  1. Bleeding episode [ Time Frame: 12 months ]
    The time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding


Secondary Outcome Measures :
  1. Ischemic episode [ Time Frame: 12 months ]
    The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients undergoing percutaneous coronary intervention
  • Indication to dual antiplatelet therapy for at least 3 months

Exclusion Criteria:

- Contraindications to dual antiplatelet therapy lasting more than 3 months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848572


Contacts
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Contact: Francesco Pelliccia, MD 390649971 ext 123 f.pelliccia@mclink.it
Contact: Giuseppe Marazzi, MD 3906234342 ext 123 marazzig@gmail.com

Locations
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Italy
San Raffaele Pisana
Rome, Italy, 00100
Sapienza University
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Study Chair: Carlo Gaudio, MD Sapienza University

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Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03848572     History of Changes
Other Study ID Numbers: 2019/D/101
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francesco Pelliccia, University of Roma La Sapienza:
Dual Anti-platelet Therapy
Bleeding

Additional relevant MeSH terms:
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Cardiovascular Diseases