Effects of Cangrelor on MIcRovAscular Disfunction During Elective Percutaneous CORonary Intervention

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Dual Antiplatelet Therapy represents the main therapy for patients presenting with chronic coronary syndromes and undergoing elective PCI. However, most of these patients are not properly covered in terms of inhibition of platelets aggregation at the time of PCI, and are exposed to an higher risk of microvascular damage which in turns might be responsible of residual symptoms persistence and the findings of residual ischemia at the non-invasive tests. In naïve patients, cangrelor can be administered at the time of PCI potentially protecting coronary microcirculation. The aim of this randomized study is indeed to evaluate the use of Cangrelor as compared with standard practice (with Clopidogrel) in terms of incidence of coronary microvascular dysfunction following elective PCI of functionally significant intermediate coronary stenoses. All consecutive patients, fulfilling inclusion and exclusion criteria, will be enrolled and both FFR and CFR/IMR will be measured before and after PCI. Platelet reactivity will be also evaluated mainly during PCI procedure. At 30 days of follow up, patients will be interrogated about symptoms persistence and will be asked to complete the specific Seattle Angina Questionaty (SAQ7). At 3 months a SPECT could be performed in order to evaluate the presence of residual ischemic area in the myocardial territory downstream to the treated vessel. With this study we will be able to evaluate the potential benefit of using Cangrelor, as compared with standard therapy with Clopidogrel, in terms of protection of coronary microcirculation during elective PCI and reduction of both residual symptoms and ischemia at clinical follow up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients;

• Signed Informed Consent;

• Chronic coronary syndromes;

• P2Y12-inhibitors naive patients;

• Elective PCI of a functionally significant (FFR ≤ 0.80) de-novo intermediate coronary artery stenoses in a major vessel;

Locations
Other Locations
Italy
Division of Cardiology, University Hospital of Ferrara
NOT_YET_RECRUITING
Ferrara
Division of Cardiology - Federico II University Hospital
RECRUITING
Naples
Contact Information
Primary
Luigi Di Serafino, MD, PhD
luigi.diserafino@unina.it
+390817462235
Backup
Alessandra Spinelli
alessandra.spinelli@unina.it
+390817462274
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 80
Treatments
Experimental: Cangrelor
In the Experimental group, before performing PCI, all patients will be treated with Cangrelor (Kangrexal) with an i.v. loading bolus (30mg/Kg) followed by i.v. infusion (4mg/Kg/min) for 2 hours. At the end of the infusion, as per current clinical practice, a loading dose of Clopidogrel (600mg) will be administered. A manteinance daily dose of 75mg will be associated with oral ASA (100mg).
No_intervention: Control
In the Control group, either before or after PCI a loading dose of Clopidogrel will be administered and a manteinance daily dose of 75mg will be associated with oral ASA (100mg). PCI procedure will be performed as per current cinical practice, according clinical guidelines and at operator discretion.
Sponsors
Leads: Federico II University

This content was sourced from clinicaltrials.gov