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Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI.
Prospective, observational, multicenter registry.
SCAD patients routinely in the Italian centers undergo complex PCIs with pre-treatment with P2Y12 inhibitors or with P2Y12 inhibitors administration after procedure. This implies that participants receive interventions as part of routine medical care, and that researchers actually observe the effect of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI with pre-treatment with P2Y12 inhibitors | SCAD patients undergoing complex PCI with pre-treatment with P2Y12 inhibitors will undergo:
| ||
| PCI with treatment with P2Y12 inhibitors only after procedure. | SCAD patients undergoing complex PCI with treatment with P2Y12 inhibitors only after procedure will undergo:
|
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| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification. | Number of patients with intracranial hemorrhage or a ≥5 g/dl decrease in hemoglobin concentration or a ≥15 % absolute decrease in hematocrit. | hour 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint: Long-term major adverse cardiac and cerebrovascular events MACCE (eg Death from any cause, Any Myocardial infarction, Revascularization, Stroke) | Number of patients with Long-term major adverse cardiac and cerebrovascular events (MACCE) (e.g. Death from any cause, Any Myocardial infarction, Revascularization, Stroke) | hour 48 and day 30 |
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Inclusion Criteria:
Patient must be at least 65 years of age at the time of signing the Informed Consent Form
Patient presenting with SCAD undergoing complex PCI and:
Patient is to be treated for de novo lesions located in previously untreated vessels.
Patient must agree to undergo all required follow-up visits and data collection.
Exclusion Criteria:
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Patients with SCAD undergoing complex PCI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alfredo Marchese, MD, PhD | Contact | +390805040376 | alfma@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| Alfredo Marchese, MD, PhD | Ospedale Santa Maria (BA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Santa Maria | Bari | Apulia | 70124 | Italy |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Assessment of platelet reactivity | Assessment of platelet reactivity measured by the VerifyNow® P2Y12 assay. Pharmacodynamic measurements will occur according to manufacturer instructions before, during, and after study drug infusion. | Day 0 |
| Number of Participants with stent thrombosis | Number of Participants with stent thrombosis demonstrated by coronary angiography | hour 48 |
| Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification. | Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification. | Day 30 |
| Time to Coronary Artery Bypass Graft (CABG) | Time between the intervention and the Coronary Artery Bypass Graft (CABG) | Day 30 |