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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04251039
• Other study ID #: RESPONSE V 0.4 31/10/2019
• Status: Not yet recruiting
• Start date: December 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Fondazione GISE Onlus
• Contact: Alfredo Marchese, MD, PhD
• Phone: +390805040376
• Email: alfma[@]libero.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Prospective, observational, multicenter registry.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Disease

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria	Bari	Puglia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione GISE Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Participants with stent thrombosis	Number of Participants with stent thrombosis demonstrated by coronary angiography	hour 48
Secondary	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
Secondary	Time to Coronary Artery Bypass Graft (CABG)	Time between the intervention and the Coronary Artery Bypass Graft (CABG)	Day 30