Short-term Dual Anti Platelet Therapy in Patients With ACS Treated With the COMBO Dual-therapy Stent
Status:
Completed
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
Background:
The optimal duration of dual antiplatelet therapy in ACS patients treated with DES is still
under debate. This is especially true for STEMI patients in the era of new anticoagulants and
antiplatelet agents. Yet, the potential benefits of longterm dual antiplatelet therapy in
avoiding thrombotic complications may be clearly counterbalanced by a higher risk of major
bleeding complications. In particular, the COMBO dual therapy stent, being associated with
early re-endothelization, may allow for a reduction of the duration of DAPT (dual anti
plateled therapy) without increasing the thrombotic risk, while reducing the risk of severe
bleeding complications.
Study Objective:
Aim of the current study is to demonstrate a non-inferiority of a strategy of short-term DAPT
(90 days) as compared to standard 360 days DAPT in ACS patients treated with Combo stent.
Study Design:
This study is a prospective, multicenter, randomized, investigator-initiated study designed
to enroll 1500 patients with ACS receiving a COMBO dual-therapy stent who will be randomized
1:1 to either short term (90 days) or to standard (360 days) DAPT. Patients will be
randomized within hospitalization (before discharge in case additional revascularization is
deemed necessary and performed during hospitalization). Clinical visit is scheduled at 90,
and 360 days, whereas a telephone contact will be performed at 180 and 720 days.
Patient Population:
The study population will consist of up to 1500 ACS patients (male and female) older than 18
years amenable to percutaneous treatment and treated with a COMBO stent. Subjects must meet
all of the eligibility criteria and provide written informed consent.