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

Fondazione GISE Onlus

Status: Not yet enrolling

Conditions: Coronary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04251039

RESPONSE V 0.4 31/10/2019

Details and patient eligibility

About

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

Prospective, observational, multicenter registry.

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

550 participants in 2 patient groups

PCI with pre-treatment with P2Y12 inhibitors

Description:

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)

PCI with treatment with P2Y12 inhibitors only after procedure.

Description:

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)