A Prospective muLticEnter Registry in chrONic coronARy synDrOme

NCT06198673 | Not Yet Recruiting

• 1 other identifier: 2023/D/18122023
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Frequency of 'naive' patients with CCS undergoing elective PCI

  Number of 'naive' patients with CCS undergoing elective PCI

  up to 12 months

• Frequency of complex coronary intervention in patients undergoing elective PCI

  Number of complex coronary intervention in patients undergoing elective PCI

  up to 12 months

Interventions

Antiplatelet Agents DRUG

Antiplatelet agents more commonly used at time of percutaneous coronary intervention in patients with chronic coronary syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with CCS undergoing elective PCI. Patients will be grouped as follows: * Pre-treatment with clopidogrel before elective PCI * Patients receiving a clopidogrel loading at time of elective PCI in the cath lab Patients receiving cangrelor during PCI in the cath lab and then receiving a P2Y12 inhibitor afterwards

You may qualify if:

• 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

You may not qualify if:

• Patients with active bleeding
• Patients with hypersensitivity to any anti-platelet agents or to any of its excipients
• Known pregnancy or breast-feeding female patients

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Francesco Pelliccia, MD

  University Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+394997; f.pelliccia@mclink.it

Carlo Gaudio, MD

CONTACT

+394997

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR OF CARDIOLOGY

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 10, 2024

Record last verified: 2023-12