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

• Published in: Cardiovascular diabetology Vol. 16; no. 1; p. 68
• Main Authors: Cerrato, Enrico, Quirós, Alicia, Echavarría-Pinto, Mauro, Mejia-Renteria, Hernan, Aldazabal, Andres, Ryan, Nicola, Gonzalo, Nieves, Jimenez-Quevedo, Pilar, Nombela-Franco, Luis, Salinas, Pablo, Núñez-Gil, Iván J, Rumoroso, José Ramón, Fernández-Ortiz, Antonio, Macaya, Carlos, Escaned, Javier
• Format: Journal Article
• Language: English
• Published: England BioMed Central 19.05.2017; BMC
• Subjects: Acute coronary syndromes; Adenosine; Adenosine - adverse effects; Adenosine - analogs & derivatives; Adenosine - therapeutic use; Blood platelets; Blood Platelets - drug effects; Blood Platelets - metabolism; Cardiology; Cardiovascular disease; Clinical Protocols; Clinical trials; Clopidogrel; Coronary Artery Disease - blood; Coronary Artery Disease - complications; Coronary Artery Disease - physiopathology; Coronary Artery Disease - therapy; Coronary Circulation - drug effects; Coronary vessels; Design; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Embolization; Heart attacks; Humans; Hypotheses; Impairment; IMR, CFR, FFR; Injuries; Microcirculation; Microcirculation - drug effects; Microvasculature; Patients; Percutaneous Coronary Intervention - adverse effects; Physiology; Platelet Aggregation Inhibitors - adverse effects; Platelet Aggregation Inhibitors - therapeutic use; Prospective Studies; Purinergic P2Y Receptor Antagonists - adverse effects; Purinergic P2Y Receptor Antagonists - therapeutic use; Research Design; Risk Factors; Rodents; Spain; Study Protocol; Ticagrelor; Ticlopidine - adverse effects; Ticlopidine - analogs & derivatives; Ticlopidine - therapeutic use; Time Factors; Treatment Outcome; Vasodilation - drug effects; Microcirculation; Diabetes; Ticagrelor; IMR, CFR, FFR
• ISSN: 1475-2840; 1475-2840
• DOI: 10.1186/s12933-017-0543-5

In 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. PREDICT 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). PREDICT 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).