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

"Efficacy and Safety of Oral/iv Therapy (Cangrelor) in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"

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

Prospective, observational, multicenter registry.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Disease

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 Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

• Study Contact: Name: Alfredo Marchese, MD, PhD; Phone Number: +390805040376; Email: alfma@libero.it

Study Locations

• Italy
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Ospedale Santa Maria
      • Contact: Alfredo Marchese, MD, PhD
      • Principal Investigator: Alfredo Marchese, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with SCAD undergoing complex PCI

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Fondazione GISE Onlus
• Investigators: Principal Investigator: Alfredo Marchese, MD, PhD, Ospedale Santa Maria (BA)

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: RESPONSE V 0.4 31/10/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No