Effects of P2Y12 Receptor Inhibitors on Central and Peripheral Chemoreceptors' Sensitivity
NCT ID: NCT05080478
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2018-11-01
2022-08-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A
patients receiving ticagrelor 90mg bid
Clopidogrel, 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.
Group B
patients receiving clopidogrel 75mg qd
Clopidogrel, 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.
Interventions
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Clopidogrel, 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.
Eligibility Criteria
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Inclusion Criteria
* Age 18 - 80 years
* Planned treatment with ticagrelor or clopidogrel (according to European Cardiology Society guidelines)
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Stanisław Tubek
Medical Doctor
Locations
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Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PREL.E190.18.004
Identifier Type: -
Identifier Source: org_study_id