Short-term Dual Anti Platelet Therapy in Patients With ACS Treated With the COMBO Dual-therapy Stent (REDUCE)
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.
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.
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.
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.
|Acute Coronary Syndrome||Drug: Treatment 90 days DAPT Drug: Treatment 360 days DAPT||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt|
- Composite of all cause mortality, Myocardial Infarction (MI), ST, stroke, bleeding at 360 days [ Time Frame: At 360 days ]
- Prespecified landmark analysis of Primary Endpoint from 90 days to 360 days,Bleeding at 360 days, All cause mortality, MI, ST, stroke, bleeding at 720 days, All cause mortality, MI, ST, stroke at 360 and 720 days [ Time Frame: 90, 360 and 720 days ]
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Active Comparator: DAPT 360 days
Treatment 360 days DAPT
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
Active Comparator: DAPT 90 days
Treatment 90 days DAPT
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.
Up to 40 investigational sites in Europe and Asia
Follow-up (clinic) visits are scheduled at 90 and 360 days, whereas a telephone contact will be performed at 180 and 720 days. Patients randomized to short-term DAPT will continue on monotherapy with ASA after 90 days unless contraindicated.
Subjects will be treated with Aspirin and P2Y12 inhibitor. Prasugrel (10 mg/day) or Ticagrelor (180 mg/day) are strongly recommended as compared to Clopidogrel (75 mg/day)). Long term 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 Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue.
Initial Enrollment: March 2014, Last Enrollment: May 2016, One year Follow-up: May 2018, Two year Follow-up: May 2019
Please refer to this study by its ClinicalTrials.gov identifier: NCT02118870
|Zwolle, Overijssel, Netherlands, 8025 AB|
|Principal Investigator:||H. Suryapranata, Prof. dr.||Radboud University Medical Center, Nijmegen, The Netherlands|
|Principal Investigator:||G. de Luca, Prof. dr.||Eastern Piedmont University, Novara, Italy|