Repetitive Assessement of PRECISE-DAPT Score

Cardiovascular Diseases Clinical Trial

— RE-SCORE  

Official title:

A Randomized Study of Repetitive Assessement of PRECISE-DAPT Score During Dual Antiplatelet Therapy: The RE-SCORE Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848572
• Other study ID #: 2019/D/101
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Interventional Cardiology

Intervention

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

Locations

Country	Name	City	State
Italy	San Raffaele Pisana	Rome
Italy	Sapienza University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding episode	The time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding	12 months
Secondary	Ischemic episode	The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization	12 months