Repetitive Assessement of PRECISE-DAPT Score

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Interventional Cardiology
• Interventions: Diagnostic Test: Repetitive assessment of PRECISE-DAPT score

• Registration Number: NCT03848572
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Re-Score strategy	Repetitive assessment of PRECISE-DAPT score	Patients will enter a novel strategy of 12-month follow with repetitive assessment of PRECISE-DAPT score at 3-month intervals

Primary Outcome Measures

Name	Time	Method
Bleeding episode	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

Name	Time	Method
Ischemic episode	12 months	The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization

Trial Locations

Locations (2)

San Raffaele Pisana; 🇮🇹 Rome, Italy

Sapienza University; 🇮🇹 Rome, Italy