Effects of Cangrelor on MIcRovAscular Disfunction During Elective Percutaneous CORonary Intervention

NCT06089577 | Recruiting Phase 4

• 1 other identifier: 373/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Dual Antiplatelet Therapy represents the main therapy for patients presenting with chronic coronary syndromes and undergoing elective PCI. However, most of these patients are not properly covered in terms of inhibition of platelets aggregation at the time of PCI, and are exposed to an higher risk of microvascular damage which in turns might be responsible of residual symptoms persistence and the findings of residual ischemia at the non-invasive tests. In naïve patients, cangrelor can be administered at the time of PCI potentially protecting coronary microcirculation. The aim of this randomized study is indeed to evaluate the use of Cangrelor as compared with standard practice (with Clopidogrel) in terms of incidence of coronary microvascular dysfunction following elective PCI of functionally significant intermediate coronary stenoses. All consecutive patients, fulfilling inclusion and exclusion criteria, will be enrolled and both FFR and CFR/IMR will be measured before and after PCI. Platelet reactivity will be also evaluated mainly during PCI procedure. At 30 days of follow up, patients will be interrogated about symptoms persistence and will be asked to complete the specific Seattle Angina Questionaty (SAQ7). At 3 months a SPECT could be performed in order to evaluate the presence of residual ischemic area in the myocardial territory downstream to the treated vessel. With this study we will be able to evaluate the potential benefit of using Cangrelor, as compared with standard therapy with Clopidogrel, in terms of protection of coronary microcirculation during elective PCI and reduction of both residual symptoms and ischemia at clinical follow up.

Conditions

Coronary Artery Disease

Keywords

index of microcirculatory resistance; coronary flow reserve; Cangrelor

Outcome Measures

Primary Outcomes (1)

• Incidence of microvascular dysfunction

  IMR \> 25

  within 60 minutes post PCI procedures

Secondary Outcomes (5)

• Periprocedural platelect reactivity

  within 60 minutes post PCI procedures

• Periprocedural platelect reactivity

  within 180 minutes post PCI procedures

• Incidence of Periprocedural myocardial infarction

  within 24 hours post PCI procedures

• Incidence of Residual Angina

  30 days post PCI

• Incidence of residual ischemia

  90 days post PCI

Study Arms (2)

Cangrelor

EXPERIMENTAL

In the Experimental group, before performing PCI, all patients will be treated with Cangrelor (Kangrexal) with an i.v. loading bolus (30mg/Kg) followed by i.v. infusion (4mg/Kg/min) for 2 hours. At the end of the infusion, as per current clinical practice, a loading dose of Clopidogrel (600mg) will be administered. A manteinance daily dose of 75mg will be associated with oral ASA (100mg).

Drug: Cangrelor 50 MG

Control

NO INTERVENTION

In the Control group, either before or after PCI a loading dose of Clopidogrel will be administered and a manteinance daily dose of 75mg will be associated with oral ASA (100mg). PCI procedure will be performed as per current cinical practice, according clinical guidelines and at operator discretion.

Interventions

Cangrelor 50 MG DRUG

Cangrelor will be administered during PCI

Cangrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients;
• Signed Informed Consent;
• Chronic coronary syndromes;
• P2Y12-inhibitors naive patients;
• Elective PCI of a functionally significant (FFR ≤ 0.80) de-novo intermediate coronary artery stenoses in a major vessel;

You may not qualify if:

• Underaged patients;
• Acute Conorary Syndromes;
• Already on treatment with P2Y12-inhibitors;
• Heart failure with severe reduction of the left ventricle ejection fraction (LVEF \< 30%);
• Subtotal occlusion (diameter stenosis \> 90%) of the target lesion;

Sponsors & Collaborators

• Federico II University: lead

Study Sites (2)

Division of Cardiology, University Hospital of Ferrara

Ferrara, 44124, Italy

NOT YET RECRUITING

Division of Cardiology - Federico II University Hospital

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Luigi Di Serafino, MD, PhD

CONTACT

+390817462235; luigi.diserafino@unina.it

Alessandra Spinelli

CONTACT

+390817462274; alessandra.spinelli@unina.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology, MD, PhD

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 18, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

IT (2)