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NCT06198673Not yet recruiting

A Prospective muLticEnter Registry in chrONic coronARy synDrOme

Real-world Patterns of Anti-platelet Management in Stable Angina Patients Undergoing Percutaneous Coronary Intervention

Source: ClinicalTrials.gov · Last updated 10 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

In patients with chronic coronary syndrome (CCS), clopidogrel has a class I/A indication in patients undergoing elective percutaneous coronary intervention (PCI). Although unproven, the possibility exists that clopidogrel does not yield an optimal platelet inhibition in multiple real-world scenarios that challenge current recommendations. The aim of this prospective observational study io assess in a consecutive unselected series of patients with CCS undergoing elective PCI the frequency of the following real world clinical scenarios: * No pretreatment at time of PCI ('naïve') * Evidence of incomplete responsiveness to clopidogrel * Indication to a complex PCI. We expect to demonstrate: * A not negligible proportion of patients with CCS are 'naïve' at time of elective PCI in clinical practice and require a rapid onset of P2Y12 inhibition. * A substantial proportion of patients with CCS who are treated with clopidogrel prior to elective PCI have high platelet responsiveness at time of the procedure. * A complex PCI is performed in a substantial proportion of patients with CCS.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
26 Dec 2023
Start date
1 Jan 2024
Primary completion date
31 Dec 2025
Lead sponsor
University of Roma La Sapienza
NCT number
NCT06198673

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Jan 2024 to the primary completion date, 31 Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with active bleeding

Lab values

  • Patients with hypersensitivity to any anti-platelet agents or to any of its excipients

Other

  • Known pregnancy or breast-feeding female patients

Who the study is looking for

  • Patients with CCS undergoing elective PCI
  • Patients' written informed and privacy consent obtained before the PCI procedure
  • Male or female patients 18 to 80 years old
  • Assessment of response to anti-platelet agents by VerifyNowTM

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.