in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"

NCT ID: NCT04251039

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2023-12-31

Brief Summary

Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI.

Prospective, observational, multicenter registry.

Detailed Description

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.

Conditions

Coronary Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

PCI with pre-treatment with P2Y12 inhibitors

SCAD patients undergoing complex PCI with pre-treatment with P2Y12 inhibitors will undergo:

• Assessment of platelet reactivity (Time 0, T0) (VFN)
• PCI (start = T1; end= T2)

No interventions assigned to this group

PCI with treatment with P2Y12 inhibitors only after procedure.

SCAD patients undergoing complex PCI with treatment with P2Y12 inhibitors only after procedure will undergo:

• Administration of Cangrelor (bolus + infusion of at least 2 hours and at least until end of PCI) or decision to not administer (T0)
• Assessment of platelet reactivity (Time 0, T0) (VFN)
• PCI (start of PCI= T1; end of infusion of Cangrelor= T2)

No interventions assigned to this group

Eligibility Criteria

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:

• Type 2 Diabetes Mellitus;
• CKD (Grade specified in CRF);
• Complex SCAD: LMD, 3VD, bifurcation lesions, Rotablator, CTO, multiple Stents, total length of the stents must be greater than 60 mm.
• 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

• History of CABG;
• In stent restenosis;
• Patient with intolerance or contra-indications to treatment with aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, heparin, contrast media;
• Patient on chronic treatment with oral anticoagulants;
• Patient with neoplastic or rheumatic diseases;
• Use of dipyridamole, cilostazol, or anticoagulant therapy during the study period;
• Bleeding disorder
• History of an ischemic stroke or intracranial bleeding
• Intracranial vascular abnormality;
• Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days.
• Women who are pregnant/breastfeeding or who have the potential to become pregnant during the study;
• Patient with bleeding diathesis in whom antiplatelet drug is contraindicated;
• Concomitant indication to open heart surgery
• Inability to provide written informed consent
• Enrolment in another study within 1 month

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione GISE Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo Marchese, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Santa Maria (BA)

Locations

Ospedale Santa Maria

Bari, Apulia, Italy

Countries

Italy

Central Contacts

Alfredo Marchese, MD, PhD

Role: CONTACT

alfma@libero.it

+390805040376

Facility Contacts

Alfredo Marchese, MD, PhD

Role: primary

Other Identifiers

RESPONSE V 0.4 31/10/2019

Identifier Type: -

Identifier Source: org_study_id