First Patient Enrolled in Investigator Initiated REDUCE Study

ZWOLLE, The Netherlands, June 13, 2014 /PRNewswire/ --

Randomized Evaluation of short-term DUal antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO^TM Dual-Therapy StEnt

The Principal Investigators of the REDUCE trial announce the enrolment of the first patient in the REDUCE trial with the OrbusNeich COMBO Dual Therapy Stent at Isala Hospital, Zwolle, the Netherlands.

According to the local PI and treating physician, Doctor E. Kedhi, MD, PhD, the 81-year-old female patient was successfully treated with the COMBO Stent. The patient consented enrolment in the trial, and was randomized to one of the two treatment arms involving either three months or 12 months of Dual Antiplatelet Therapy (DAPT).

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 long-term 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-endothelialization, may allow for a reduction of the duration of DAPT without increasing the thrombotic risk, while reducing the risk of severe bleeding complications.

Objective

It is the aim of the current study to demonstrate non-inferiority of a strategy of short-term DAPT (three months) as compared to standard 12-month DAPT in ACS patients treated with the COMBO Stent.

Study Design

The REDUCE study is a prospective, multicenter, randomized, investigator-initiated study designed to enroll 1,500 patients with ACS who will receive a COMBO Dual Therapy Stent. Patients will be randomized 1:1 to either short term (three months) or standard (12 months) DAPT within the hospitalization period (before discharge in case additional revascularization is deemed necessary and performed during hospitalization). Clinical follow-ups are scheduled at three, six, 12 and 24 months. Thirty hospitals in Asia and Europe will participate in the study. Diagram is the appointed contract research organization for the REDUCE study.

Patient Population

The study population will consist of up to 1,500 ACS patients (male and female) older than 18 years who have been treated with the COMBO Stent. Subjects must meet all of the eligibility criteria and provide written informed consent.

Primary Endpoint

The primary endpoint of the study is composite of all-cause mortality, Myocardial Infarction (MI), stent thrombosis (ST), stroke, target vessel revascularization (TVR) or bleeding (BARC II, III, V) at 12 months.

Principal Investigators
H. Suryapranata, MD, PhD, UMC St.Radboud, Nijmegen, The Netherlands
G. De Luca, MD, PhD, Novara Hospital, Novara, Italy

For more information about the REDUCE trial, please visit https://clinicaltrials.gov/ct2/show/NCT02118870

About Diagram

Diagram is a globally operating, full service Contract Research Organization (CRO) with two Site Management Organizations (SMOs). Diagram is able to support the development, organization and execution of clinical scientific research. Diagram was founded in 1996 in the Netherlands. In the past years, Diagram has acquired considerable expertise in supporting cardiovascular research and has the ambition to gain expertise in supporting other research areas. The quality management of Diagram (NEN-EN-ISO 9001:2008 certified), strong ICT, data management and statistics department, own SMOs and international focus makes Diagram different from other CROs. Please visit http://www.diagram-zwolle.nl.

About OrbusNeich

OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first dual therapy stent, the COMBO Dual Therapy Stent, and the world's first pro-healing stent, the Genous™ Stent. Other products include stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit http://www.OrbusNeich.com.