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

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ClinicalTrials.gov Identifier: NCT05080478
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Stanisław Tubek, Wroclaw Medical University

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.


Condition or disease Intervention/treatment
Dyspnea Drug: Clopidogrel, Ticagrelor

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of P2Y12 Receptor Inhibitors on Central and Peripheral Chemoreceptors' Sensitivity
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group A
patients receiving ticagrelor 90mg bid
Drug: 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
Drug: 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.




Primary Outcome Measures :
  1. The influence of P2Y12 inhibitors on peripheral and central chemosensitivity [ Time Frame: up to 5 weeks ]
    Absolute change in central and peripheral chemosensitivities separately for groups A and B



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080478


Contacts
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Contact: Stanislaw Tubek, MD, PhD 00 48 71 733 11 12 stanislaw.tubek@umw.edu.pl

Locations
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Poland
Wroclaw Medical University Recruiting
Wrocław, Dolnośląskie, Poland
Contact: Stanislaw Tubek    00 48 71 733 11 12    stanislaw.tubek@umw.edu.pl   
Sponsors and Collaborators
Wroclaw Medical University
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Responsible Party: Stanisław Tubek, Medical Doctor, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT05080478    
Other Study ID Numbers: PREL.E190.18.004
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs