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

Wroclaw Medical University

Status

Unknown

Conditions

Dyspnea

Treatments

Drug: Clopidogrel, Ticagrelor

Study type

Observational

Funder types

Other

Identifiers

NCT05080478

PREL.E190.18.004

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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