PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor (PREDICT): study rationale and design. A randomized multicenter clinical trial using intracoronary multimodal physiology

Cardiovascular Diabetology

Study Protocol

Luis Nombela-Franco¹  Carlos Macaya¹  Iván J. Núñez-Gil¹  Mauro Echavarría-Pinto¹  Pablo Salinas¹  Nicola Ryan¹  Pilar Jimenez-Quevedo¹  Antonio Fernández-Ortiz¹  Javier Escaned¹  Nieves Gonzalo¹  Andres Aldazabal¹  Alicia Quirós¹  Hernan Mejia-Renteria¹  Enrico Cerrato²  José Ramón Rumoroso³ 

[1] Unidad de Cardiología Intervencionista, Hospital Clínico San Carlos, 28040, Madrid, Spain;Unidad de Cardiología Intervencionista, Hospital Clínico San Carlos, 28040, Madrid, Spain;Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano and Infermi Hospital, Rivoli, Turin, Italy;Unidad de Cardiología Intervencionista, Hospital Galdakao, Bilbao, Spain;

关键词: Diabetes;    IMR, CFR, FFR;    Microcirculation;    Ticagrelor;   

DOI  :  10.1186/s12933-017-0543-5

 received in 2017-01-09, accepted in 2017-04-28,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundIn diabetic patients a predisposed coronary microcirculation along with a higher risk of distal particulate embolization during primary percutaneous intervention (PCI) increases the risk of peri-procedural microcirculatory damage. However, new antiplatelet agents, in particular Ticagrelor, may protect the microcirculation through its adenosine-mediated vasodilatory effects.MethodsPREDICT is an original, prospective, randomized, multicenter controlled study designed to investigate the protective effect of Ticagrelor on the microcirculation during PCI in patient with diabetes mellitus type 2 or pre-diabetic status. The primary endpoints of this study aim to test (i) the decrease in microcirculatory resistance with antiplatelet therapy (Ticagrelor > Clopidogrel; mechanistic effect) and (ii) the relative microcirculatory protection of Ticagrelor compared to Clopidogrel during PCI (Ticagrelor < Clopidogrel; protective effect).ConclusionsPREDICT will be the first multicentre clinical trial to test the adenosine-mediated vasodilatory effect of Ticagrelor on the microcirculation during PCI in diabetic patients. The results will provide important insights into the prospective beneficial effect of this drug in preventing microvascular impairment related to PCI (http://www.clinicaltrials.gov No. NCT02698618).

【 授权许可】

CC BY   
© The Author(s) 2017