Repetitive Assessement of PRECISE-DAPT Score

NCT ID: NCT03848572

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Cardiovascular Diseases; Interventional Cardiology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual care

Patients will enter standard 12-month clinical follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Re-Score strategy

Patients will enter a novel strategy of 12-month follow with repetitive assessment of PRECISE-DAPT score at 3-month intervals

Group Type: EXPERIMENTAL

Repetitive assessment of PRECISE-DAPT score

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pelliccia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Gaudio, MD

Role: STUDY_CHAIR

Sapienza University

Locations

San Raffaele Pisana

Rome, , Italy

Sapienza University

Rome, , Italy

Countries

Italy

Other Identifiers

2019/D/101

Identifier Type: -

Identifier Source: org_study_id