Effects of Ticagrelor Versus Prasugrel on Coronary Microcirculation in Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the PROtecting MICROcirculation During Coronary Angioplasty (PROMICRO)-3 Randomised Study

• Status: Completed
• Trial end date: 2019-04-14
• Target enrollment: 0
• Participant gender: All

Summary

Besides being at least as effective as prasugrel in inhibiting platelet aggregation, ticagrelor has been shown to have additional properties potentially affecting coronary microcirculation. We sought to compare the effects of ticagrelor and prasugrel on absolute coronary blood flow (Q) and microvascular resistance (R) in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI).

The PROMICRO-3 study shows that in patients with stable CAD undergoing PCI pre-treatment with a loading dose of ticagrelor compared with prasugrel improves post-procedural coronary flow and microvascular function and seems to reduce the related myocardial injury.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germano Di Sciascio
• Collaborators: CardioRISC, C-TRIC, Derry/Londonderry, Northern Ireland, UK; Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy; Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland
• Treatments: Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

• Paitents with stable CAD referred to elective percutaneous coronary intervention (PCI) of an isolated, functionally significant (as confirmed by a fractional flow reserve [FFR] <0.80) stenosis located in the proximal two-thirds of a major coronary artery

Exclusion Criteria:

• age <18 years or ≥75 years, body weight <60 kg, previous transient ischemic attack (TIA) or stroke, acute coronary syndromes, administration of glycoprotein IIb/IIIa inhibitors, platelet count <70x109/l, high bleeding risk (active internal bleeding, history of haemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm, ischemic stroke in the previous 3 months), coronary bypass graft surgery in the previous 3 months, severe chronic renal failure (serum creatinine ≥2 mg/dl), previous myocardial infarction, left ventricular ejection fraction less than 50%, left ventricle wall-motion abnormalities, left ventricular hypertrophy, chronic total occlusion, lesions with extensive calcifications requiring rotational atherectomy, in-stent restenosis, bifurcation lesions with side branch diameter of more than 2 mm, ostial lesion, and contraindications to adenosine