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Search / Trial NCT05643586

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

Launched by GERMANO DI SCIASCIO · Nov 30, 2022

Trial Information

Current as of January 17, 2025

Completed

Keywords

Coronary Flow Coronary Resistances Platelet Reactivity

ClinConnect Summary

Patient population We enrolled patients naïve to platelet P2Y12 receptor inhibitors 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.

Study protocol Patients were randomly assigned to receive loading doses of either ticagrelor (180 mg) or prasugrel (60 mg) at least 12 hours before intervention. Assignment to one of the two treatments was determined by a computer-based randomization system and ...

Gender

ALL

Eligibility 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

About Germano Di Sciascio

Germano Di Sciascio is a dedicated clinical trial sponsor specializing in innovative research and development within the pharmaceutical and biotechnology sectors. With a strong commitment to advancing medical science, the organization focuses on conducting rigorous clinical trials that aim to evaluate the safety and efficacy of novel therapeutic interventions. Leveraging a multidisciplinary team of experts, Germano Di Sciascio prioritizes ethical standards and regulatory compliance, ensuring high-quality data collection and analysis. Their mission is to contribute to the improvement of patient outcomes through the successful translation of research findings into effective treatment options.

Locations

Aalst, , Belgium

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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