We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Yoshinobu Onuma, MD
+353852882318
Yoshinobu.Onuma@universityofgalway.ie
Patrick W Serruys, MD
+31622924061
Patrick.Serruys@universityofgalway.ie
Coronary Artery Disease Myocardial Ischemia Coronary Disease
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
PIONEER-IV is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance to LRDP and usual care in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent. Patients will be randomized to either angio-based physiology guidance angio-FFR (Quantitative Flow Ratio and coronary angiography-derived FFR, caFFR) or local routine diagnostic procedure (LRDP) and usual care. Patients will be treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2\*1270) patients. All patients (both cohorts) must receive dual anti-platelet therapy, being aspirin (ASA) and ticagrelor for 1 month, followed by 11 months of ticagrelor only (i.e. monotherapy). At 1 year, ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"Hara H, Serruys PW, O'Leary N, Gao C, Murray A, Breslin E, Garg S, Bureau C, Reiber JH, Barbato E, Aminian A, Janssens L, Rosseel L, Benit E, Campo G, Guiducci V, Casella G, Santarelli A, Franze A, Diaz VAJ, Iniguez A, Brugaletta S, Sabate M, Amat-Santos IJ, Amoroso G, Wykrzykowska J, von Birgelen C, Somi S, Liu T, Hofma SH, Curzen N, Trillo R, Ocaranza R, Mathur A, Smits PC, Escaned J, Baumbach A, Wijns W, Sharif F, Onuma Y; PIONEER IV trial investigator. Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design. Am Heart J. 2022 Apr;246:32-43. doi: 10.1016/j.ahj.2021.12.018. Epub 2022 Jan 3."; "34990582"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Yoshinobu Onuma, MD
+353852882318
Yoshinobu.Onuma@universityofgalway.ie
Patrick W Serruys, MD
+31622924061
Patrick.Serruys@universityofgalway.ie
The study is sponsored by National University of Ireland, Galway, Ireland
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
