Cangrelor's effects on heart function during heart procedures
Effects of Cangrelor on MIcRovAscular Disfunction During Elective Percutaneous CORonary Intervention
This study is testing if a new heart medication called Cangrelor can better protect the small blood vessels in the heart during procedures for patients with chronic heart issues compared to the usual treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 2 sites (Ferrara and 1 other locations) |
| Trial ID | NCT06089577 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of Cangrelor, an intravenous antiplatelet medication, on coronary microvascular dysfunction in patients with chronic coronary syndromes undergoing elective percutaneous coronary interventions (PCI). It compares the efficacy of Cangrelor to standard treatment with Clopidogrel in preventing microvascular damage during these procedures. Patients will be monitored for changes in coronary flow reserve and index of microcirculatory resistance before and after PCI. The goal is to determine if Cangrelor can provide better protection for the heart's microcirculation during these interventions.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic coronary syndromes who are naive to P2Y12 inhibitors and require elective PCI for intermediate coronary artery stenoses.
Not a fit: Patients with acute coronary syndromes or those already on P2Y12 inhibitors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and reduced symptoms for patients undergoing PCI.
How similar studies have performed: While the use of Cangrelor is established, this specific application in elective PCI for chronic coronary syndromes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; Exclusion Criteria: * Underaged patients; * Acute Conorary 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;
Where this trial is running
Ferrara and 1 other locations
- Division of Cardiology, University Hospital of Ferrara — Ferrara, Italy (Not_yet_recruiting)
- Division of Cardiology - Federico II University Hospital — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Luigi Di Serafino, MD, PhD
- Email: luigi.diserafino@unina.it
- Phone: +390817462235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.