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Short-term Dual Anti Platelet Therapy in Patients With ACS Treated With the COMBO Dual-therapy Stent

NCT02118870 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2019-02-08

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Treatment 90 days DAPT

Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue.

DRUG

Treatment 360 days DAPT

Long term (360 days) DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 360 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge

Sponsors & Collaborators

  • Diagram B.V.

    lead OTHER

Principal Investigators

  • H. Suryapranata, Prof. dr. · Radboud University Medical Center

  • G. de Luca, Prof. dr. · Eastern Piedmont University, Novara, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-10
Primary Completion
2017-09-30
Completion
2018-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02118870 on ClinicalTrials.gov