Effects of P2Y12 Receptor Inhibitors on Central and Peripheral Chemoreceptors' Sensitivity

NCT05080478 | Unknown

• 1 other identifier: PREL.E190.18.004
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Research project objectives: Most common complication of P2Y12 inhibitors treatment, particularly with ticagrelor, is dyspnea reported in 0 to 9.3% and in 10 to 38.6% of patients taking clopidogrel and ticagrelor respectively. Pathogenesis of the P2Y12 inhibitors-induced dyspnea is unknown; however, recently published case reports suggests activation of chemosensory areas. The primary objective of this study is to assess the influence of most commonly used in clinical practice P2Y12 inhibitors - ticagrelor and clopidogrel - on central and peripheral chemosensitivities. The secondary objective of the study is to define the relationship between baseline chemosensitivity (assessed before the drug initiation) and the occurrence of dyspnea after the drug administration. Methodology: Patients undergoing percutaneous coronary angioplasty (PCI), who according to current European Cardiac Society Guidelines are prescribed with various P2Y12 inhibitors (drug choice depends on individual clinical situation), will be enrolled to the study. Patients will be assigned to 2 groups depending on the type of P2Y12 inhibitor prescribed: Group A -patients receiving ticagrelor, Group B -patients receiving clopidogrel. In both groups chemosensitivity assessment will be performed before P2Y12 inhibitor administration and after the drug initiation. Patients will be additionally asked to fill the questionnaire regarding dyspnea sensation during the treatment (VAS scale and investigator-designed questionnaire). Peripheral chemosensitivity assessment will be performed using transient hypoxia method, when progressive hypercapnic test will be employed to test central chemosensitivity. Blinded recordings of chemosensitivity tests will be analyzed by researcher not involved in data collection. Chemosensitivities prior to and after drugs initiation will be compared separately for groups A and B using appropriate statistical tests. The results of dyspnea sensation questionnaire will be compared between patients with high- and low- peripheral chemosensitivity (assessed before P2Y12 inhibitor initiation) within particular groups.

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

• The influence of P2Y12 inhibitors on peripheral and central chemosensitivity

  Absolute change in central and peripheral chemosensitivities separately for groups A and B

  up to 5 weeks

Study Arms (2)

Group A

patients receiving ticagrelor 90mg bid

Drug: Clopidogrel, Ticagrelor

Group B

patients receiving clopidogrel 75mg qd

Drug: Clopidogrel, Ticagrelor

Interventions

Clopidogrel, Ticagrelor DRUG

P2Y12 inhibitors are prescribed following the PCI procedure in patients. Patients are enrolled on the study before administration of the first dose of the drug. Parameters are measured before and after drug initiation.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized due to stable coronary artery disease and scheduled for interventional treatment in Hear Diseases Clinic of Wroclaw Medical University will be invited to enter the study.

You may qualify if:

• Stable coronary artery disease scheduled for invasive treatment
• Age 18 - 80 years
• Planned treatment with ticagrelor or clopidogrel (according to European Cardiology Society guidelines)

You may not qualify if:

• Hypersensitivity to ticagrelor or clopidogrel
• Active pathological bleeding
• History of intracranial haemorrhage
• Severe hepatic impairment
• Other contraindications to the use of ticagrelor or clopidogrel
• A need for oral anticoagulation therapy
• Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
• Untreated, clinically significant bradycardia or atrio-ventricular conduction disorders
• Patients requiring haemodialysis
• Clinically significant anemia and/or thrombocytopenia
• Pregnancy or breastfeeding
• Scheduled coronary artery bypass grafting (CABG)
• Any severe valvular heart disease requiring further interventional or surgical treatment
• Symptomatic bronchial asthma
• Chronic obstructive pulmonary disease (COPD) in stage C or D according to GOLD

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

RECRUITING

MeSH Terms

Conditions

Dyspnea

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Stanislaw Tubek, MD, PhD

CONTACT

00 48 71 733 11 12; stanislaw.tubek@umw.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 15, 2021
• Study Start: November 1, 2018
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

PL (1)