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

NCT04251039 | Unknown

• 1 other identifier: RESPONSE V 0.4 31/10/2019
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI. Prospective, observational, multicenter registry.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Assessment of platelet reactivity

  Day 0

• Number of Participants with stent thrombosis

  hour 48

• 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)

  Day 30

Study Arms (2)

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)

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)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with SCAD undergoing complex PCI

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione GISE Onlus: lead

Study Sites (1)

Ospedale Santa Maria

Bari, Apulia, 70124, Italy

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Alfredo Marchese, MD, PhD

  Ospedale Santa Maria (BA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfredo Marchese, MD, PhD

CONTACT

+390805040376; alfma@libero.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 31, 2020
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

IT (1)