DyspneaNCT05080478
Effects of P2Y12 Receptor Inhibitors on Central and Peripheral Chemoreceptors' Sensitivity
An observational study of Dyspnea, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- Clopidogrel, Ticagrelor
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2018to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Stable coronary artery disease scheduled for invasive treatment
- Age 18 - 80 years
- Planned treatment with ticagrelor or clopidogrel (according to European Cardiology Society guidelines)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship
Stanislaw Tubek, 00 48 71 733 11 12, stanislaw.tubek@umw.edu.pl
About this study
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
- Being tested
- Clopidogrel, Ticagrelor
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel, TicagrelorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients receiving ticagrelor 90mg bid Receives: Drug: Clopidogrel, Ticagrelor | |
| Group B | patients receiving clopidogrel 75mg qd Receives: Drug: Clopidogrel, Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of P2Y12 inhibitors on peripheral and central chemosensitivity
Absolute change in central and peripheral chemosensitivities separately for groups A and B
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Nov 2018
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanisław Tubek, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080478
- Sponsor's protocol ID
- PREL.E190.18.004
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of P2Y12 Receptor Inhibitors on Central and Peripheral Chemoreceptors' Sensitivity
- ClinicalTrials.gov ID
- NCT05080478
- Acronym / sponsor ID
- PREL.E190.18.004
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Clopidogrel, Ticagrelorpatients receiving ticagrelor 90mg bid |
| Group B | – | Drug: Clopidogrel, Ticagrelorpatients receiving clopidogrel 75mg qd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Stable coronary artery disease scheduled for invasive treatment
- Age 18 - 80 years
- Planned treatment with ticagrelor or clopidogrel (according to European Cardiology Society guidelines)
Key exclusion criteria (19 listed)
- Hypersensitivity to ticagrelor or clopidogrel
- Active pathological bleeding
- History of intracranial haemorrhage
- Severe hepatic impairment
- Other contraindications to the use of ticagrelor or clopidogrel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel, TicagrelorP2Y12 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. | Drug | Group A, Group B |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanislaw Tubek, MD, PhD (00 48 71 733 11 12, stanislaw.tubek@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of P2Y12 inhibitors on peripheral and central chemosensitivity (time frame: up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.