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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05080478
Enrollment
50
Registered
2021-10-15
Start date
2018-11-01
Completion date
2022-08-01
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea

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.

Interventions

DRUGClopidogrel, Ticagrelor

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.

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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 * Carotid artery stenting, carotid endarterectomy in medical history * NYHA IV heart failure patients * Any mental disorder, that may influence on patient's compliance * Any other, unmentioned here factor, which in the opinion of investigator may increase the risk of the procedures performed during the study

Design outcomes

Primary

MeasureTime frameDescription
The influence of P2Y12 inhibitors on peripheral and central chemosensitivityup to 5 weeksAbsolute change in central and peripheral chemosensitivities separately for groups A and B

Countries

Poland

Contacts

Primary ContactStanislaw Tubek, MD, PhD
stanislaw.tubek@umw.edu.pl00 48 71 733 11 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026