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NCT06089577RecruitingPhase 4

Effects of Cangrelor on MIcRovAscular Disfunction During Elective Percutaneous CORonary Intervention

Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
80 (estimated)
First submitted
5 Oct 2023
Start date
1 Nov 2023
Primary completion date
Oct 2025
Lead sponsor
Federico II University
NCT number
NCT06089577

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 80
  • From 1 Nov 2023 to the primary completion date, Oct 2025
  • 2 sites in 1 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.

Prior treatment

  • Already on treatment with P2Y12-inhibitors;

Other illness

  • Acute Conorary Syndromes;

Lab values

  • Heart failure with severe reduction of the left ventricle ejection fraction (LVEF \< 30%);

Other

  • Underaged patients;
  • Subtotal occlusion (diameter stenosis \> 90%) of the target lesion;

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Division of Cardiology, University Hospital of Ferrara
Coordinator of this site? Confirm its status
FerraraItalyNot yet recruiting
Division of Cardiology - Federico II University Hospital
Coordinator of this site? Confirm its status
NaplesItalyRecruiting

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