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

• Conditions: Coronary Disease

• Registration Number: NCT04251039
• Lead Sponsor: Fondazione GISE Onlus

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.

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-28
• Study Start: 2022-12
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.	hour 48	Number of patients with intracranial hemorrhage or a ≥5 g/dl decrease in hemoglobin concentration or a ≥15 % absolute decrease in hematocrit.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with stent thrombosis	hour 48	Number of Participants with stent thrombosis demonstrated by coronary angiography
Time to Coronary Artery Bypass Graft (CABG)	Day 30	Time between the intervention and the Coronary Artery Bypass Graft (CABG)
Efficacy endpoint: Long-term major adverse cardiac and cerebrovascular events MACCE (eg Death from any cause, Any Myocardial infarction, Revascularization, Stroke)	hour 48 and day 30	Number of patients with Long-term major adverse cardiac and cerebrovascular events (MACCE) (e.g. Death from any cause, Any Myocardial infarction, Revascularization, Stroke)
Assessment of platelet reactivity	Day 0	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.
Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.	Day 30	Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.

Trial Locations

Locations (1)

Ospedale Santa Maria; 🇮🇹 Bari, Puglia, Italy