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

• Sponsor: Fondazione GISE Onlus (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04251039
• Collaborator: (none)
• Enrollment: 550
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 45.9

Study Details

Study Description

Brief Summary

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

Prospective, observational, multicenter registry.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 550 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: "Efficacy and Safety of Oral/iv Therapy (Cangrelor) in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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.

3. Number of Participants with stent thrombosis [hour 48]

   Number of Participants with stent thrombosis demonstrated by coronary angiography

4. 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.

5. Time to Coronary Artery Bypass Graft (CABG) [Day 30]

   Time between the intervention and the Coronary Artery Bypass Graft (CABG)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Santa Maria	Bari	Puglia	Italy	70124

Sponsors and Collaborators

• Fondazione GISE Onlus

Investigators

• Principal Investigator: Alfredo Marchese, MD, PhD, Ospedale Santa Maria (BA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione GISE Onlus
• ClinicalTrials.gov Identifier: NCT04251039
• Other Study ID Numbers: RESPONSE V 0.4 31/10/2019
• First Posted: Jan 31, 2020
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Coronary Disease

Study Results

No Results Posted as of Jul 28, 2022