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

University of Roma La Sapienza

Status: Completed

Conditions: Cardiovascular Diseases; Interventional Cardiology

Treatments: Diagnostic Test: Repetitive assessment of PRECISE-DAPT score

Study type: Interventional

Funder types: Other

Identifiers

NCT03848572

2019/D/101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Usual care

No Intervention group

Description:

Patients will enter standard 12-month clinical follow-up

Re-Score strategy

Experimental group

Description:

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

Treatment:

Diagnostic Test: Repetitive assessment of PRECISE-DAPT score