Actively Recruiting
Effects of Cangrelor on MIcRovAscular Disfunction During Elective Percutaneous CORonary Intervention
Led by Federico II University · Updated on 2025-03-13
80
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Cangrelor on MIcRovAscular Disfunction During Elective Percutaneous CORonary Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients
- Signed Informed Consent
- Chronic coronary syndromes
- P2Y12-inhibitors naive patients
- Elective PCI of a functionally significant (FFR 80) de-novo intermediate coronary artery stenoses in a major vessel
You will not qualify if you...
- Underaged patients
- Acute Coronary Syndromes
- Already on treatment with P2Y12-inhibitors
- Heart failure with severe reduction of the left ventricle ejection fraction (LVEF < 30%)
- Subtotal occlusion (diameter stenosis > 90%) of the target lesion
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Division of Cardiology, University Hospital of Ferrara
Ferrara, Italy, 44124
Not Yet Recruiting
2
Division of Cardiology - Federico II University Hospital
Naples, Italy, 80131
Actively Recruiting
Research Team
L
Luigi Di Serafino, MD, PhD
CONTACT
A
Alessandra Spinelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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