News | August 15, 2014

First Patient Enrollment Study of Shorter-term Dual Antiplatelet Therapy in ACS Patients With OrbusNeich Stent

REDUCE study will evaluate acute coronary syndrome patients in 30 Asian and European countries who receive the Combo Dual Therapy Stent

Patient Enrollment REDUCE Sudy Combo Dual Therapy Stent OrbusNeich

August 15, 2014 — OrbusNeich announced first patient enrollment in the Randomized Evaluation of short-term Dual anti platelet therapy in patients with acute coronary syndrome treated with the Combo Dual Therapy StEnt (REDUCE) Study. The study is designed to evaluate the potential for shorter-term dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) patients treated with the Combo Dual Therapy Stent. The physician-initiated, prospective, multicenter, randomized study will enroll 1,500 patients in up to 30 centers in Asia and Europe.

Patients will be randomized in a 1:1 fashion to receive either three or 12 months of DAPT. The study’s primary endpoint is the composite of all-cause mortality, any myocardial infarction (MI), Target Vessel Revascularization (TVR), stroke and major bleeding from enrollment to 12 months.

The REDUCE study will be managed by Diagram Diagnostic Research and Management. Principal investigators are Prof. Harry Suryapranata of the Radboud University Medical Center, Nijmegen, The Netherlands; and Prof. Giuseppe de Luca of Novara Hospital, Novara, Italy. E. Kedhi, M.D., Ph.D., performed the first implant at Isala Hospital in The Netherlands.

“The dual therapy approach of the Combo Stent maintains the efficacy of monotherapy drug eluting stents while providing the benefits of accelerated stent endothelialization and healing,” said Suryapranata. “For this reason, the Combo Stent may enable us to safely reduce the duration of DAPT.”

“This would be a significant achievement, as DAPT causes a number of challenges and limitations for patients because of the potential for side effects such as significant bleeding events,” added de Luca. “The REDUCE trial is the first study to evaluate the reduction of DAPT following treatment with the Combo Stent in a randomized trial and may provide us with evidence to support the safety of three months DAPT in ACS patients.”

“The first patient enrollment in the REDUCE trial represents a critical milestone for our company, for cardiologists and for patients,” said B. Wayne Johnson, president and chief operating officer of OrbusNeich. “The trial demonstrates our commitment to taking a serious look at the ‘duration of DAPT’ question. We look forward to providing cardiologists and patients a definitive answer for how long DAPT is required with our novel approach to true arterial vessel healing.”

For more information: www.diagram-zwolle.nl.

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init