Unstable Angina PectorisPhase 4NCT02939248
Influence of Naloxone on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine
A Phase 4 study testing Crushed ticagrelor followed by morphine and Crushed ticagrelor, morphine,naloxone in people with Unstable Angina Pectoris, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
Trial summary
The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite between patients who received ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and morphine alone for unstable angina pectoris. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unstable Angina Pectoris
- What is being tested?
- Crushed ticagrelor followed by morphine and Crushed ticagrelor, morphine,naloxone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 4
- 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
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Diagnosis of unstable angina
- Male or non-pregnant female, aged 18-80 years
- Provision of informed consent for angiography and PCI
- GRACE score <140 pts
Who cannot join
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- current treatment with morphine or any opioid "mi" receptor agonist
- hypersensitivity to ticagrelor
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
- history of intracranial hemorrhage
Show all 22Show fewer
- recent gastrointestinal bleeding (within 30 days)
- history of coagulation disorders
- platelet count less than <100 x10^3/mcl
- hemoglobin concentration less than 10.0 g/dl
- history of moderate or severe hepatic impairment
- history of major surgery or severe trauma (within 3 months)
- risk of bradycardic events as judged by the investigator
- second or third degree atrioventricular block during screening for eligibility
- history of asthma or severe chronic obstructive pulmonary disease
- kidney disease requiring dialysis
- manifest infection or inflammatory state
- Killip class III or IV during screening for eligibility
- respiratory failure
- history of severe chronic heart failure (NYHA class III or IV)
- concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
- body weight below 50 kg
Trial locations and contacts
1 site in 1 country.
Poland1 site
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
About this study
Official title: Differences in the Pharmacokinetic and Pharmacodynamic Profile of Ticagrelor and Its Active Metabolite AR-C124900XX Between Patients With Unstable Angina Pectoris Treated With Crushed Ticagrelor and a Combination of Morphine and Naloxone or Morphine Alone - a Randomized Study
The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite between patients who received ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and morphine alone for unstable angina pectoris.
Read the detailed description
According to contemporary guidelines, ticagrelor is a recommended antiplatelet agent in acute coronary syndromes, including unstable angina pectoris. Quick platelet inhibition plays pivotal role in the treatment of acute coronary syndromes. As evidenced in the IMPRESSION study, analgesia with morphine delays platelet inhibition in patients with acute myocardial infarction. On the other hand, the results of the MOJITO study prove that administration of crushed ticagrelor tablets leads to quicker platelet blockage.
Taking the above into consideration, we created a pharmacokinetic/pharmacodynamic study aiming to evaluate differences between patients who received crushed ticagrelor orally followed by either 1) a combination of intravenous morphine and orally administered naloxone or 2) intravenous morphine alone.
The primary study outcome is time needed for ticagrelor and its active metabolite to reach their maximum plasma concentration in each study arm. Secondary outcomes include ticagrelor and AR-C124900XX maximum concentration and the area under the plasma concentration curve for both agents.
Platelet reactivity will be assessed with the Multiplate Analyzer in all study participants at nine predefined time points.
- Conditions
- Unstable Angina Pectoris
- Being tested
- Crushed ticagrelor followed by morphine, Crushed ticagrelor, morphine,naloxone
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crushed ticagrelor followed by morphineDrug
Also called Brilique
Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously
Crushed ticagrelor, morphine,naloxoneDrug
Also called Brilique
Crushed ticagrelor (180 mg) orally followed by morphine 5 mg intravenously and naloxone 1 mg orally
| Study group | Role | What they receive |
|---|---|---|
| Crushed ticagrelor followed by morphine | Active comparator | crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously Receives: Drug: Crushed ticagrelor followed by morphine |
| Crushed ticagrelor, morphine,naloxone | Active comparator | crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously and naloxone 1 mg orally Receives: Drug: Crushed ticagrelor, morphine,naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+naloxone arms
Measured: 6 hours
Secondary outcomes (4)
Maximum ticagrelor and AR-C124900XX concentration at 6h after administration
Measured: 6 hours
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
Measured: prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose
Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)
Measured: prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose
Platelet arbitrary aggregation units/min assessed by Multiple Electrode Aggregometry
Measured: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Angina PectorisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Kubica, Collegium Medicum w Bydgoszczy
- Investigators
- Jacek Kubica, MD., PhD., Principal investigator, Cardiology Department, Dr. A. Jurasz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939248
- Sponsor's protocol ID
- CMUMK202G
- Status last verified
- Mar 2019
- First submitted
- 18 Oct 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in the Pharmacokinetic and Pharmacodynamic Profile of Ticagrelor and Its Active Metabolite AR-C124900XX Between Patients With Unstable Angina Pectoris Treated With Crushed Ticagrelor and a Combination of Morphine and Naloxone or Morphine Alone - a Randomized Study
- ClinicalTrials.gov ID
- NCT02939248
- Acronym / sponsor ID
- CMUMK202G
- Conditions
- Unstable Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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.
The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite between patients who received ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and morphine alone for unstable angina pectoris.
Detailed description
According to contemporary guidelines, ticagrelor is a recommended antiplatelet agent in acute coronary syndromes, including unstable angina pectoris. Quick platelet inhibition plays pivotal role in the treatment of acute coronary syndromes. As evidenced in the IMPRESSION study, analgesia with morphine delays platelet inhibition in patients with acute myocardial infarction. On the other hand, the results of the MOJITO study prove that administration of crushed ticagrelor tablets leads to quicker platelet blockage.
Taking the above into consideration, we created a pharmacokinetic/pharmacodynamic study aiming to evaluate differences between patients who received crushed ticagrelor orally followed by either 1) a combination of intravenous morphine and orally administered naloxone or 2) intravenous morphine alone.
The primary study outcome is time needed for ticagrelor and its active metabolite to reach their maximum plasma concentration in each study arm. Secondary outcomes include ticagrelor and AR-C124900XX maximum concentration and the area under the plasma concentration curve for both agents.
Platelet reactivity will be assessed with the Multiplate Analyzer in all study participants at nine predefined time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crushed ticagrelor followed by morphine | Active comparator | Drug: Crushed ticagrelor followed by morphinecrushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously |
| Crushed ticagrelor, morphine,naloxone | Active comparator | Drug: Crushed ticagrelor, morphine,naloxonecrushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously and naloxone 1 mg orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures
- Diagnosis of unstable angina
- Male or non-pregnant female, aged 18-80 years
- Provision of informed consent for angiography and PCI
- GRACE score <140 pts
Key exclusion criteria (22 listed)
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- current treatment with morphine or any opioid "mi" receptor agonist
- hypersensitivity to ticagrelor
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
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 |
|---|---|---|
| Crushed ticagrelor followed by morphineAlso: BriliqueCrushed ticagrelor (180 mg) followed by morphine 5 mg intravenously | Drug | Crushed ticagrelor followed by morphine |
| Crushed ticagrelor, morphine,naloxoneAlso: BriliqueCrushed ticagrelor (180 mg) orally followed by morphine 5 mg intravenously and naloxone 1 mg orally | Drug | Crushed ticagrelor, morphine,naloxone |
Primary outcome
Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+naloxone arms
Time frame: 6 hours
4 secondary outcomes
Maximum ticagrelor and AR-C124900XX concentration at 6h after administration
Time frame: 6 hours
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
Time frame: prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose
Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)
Time frame: prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose
Platelet arbitrary aggregation units/min assessed by Multiple Electrode Aggregometry
Time frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: Yes
Related trials for Unstable Angina Pectoris
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
RecruitingObservational study
Gangwon PCI Prospective Registry
Coronary Artery Disease, Ischemic Heart Disease (IHD)
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI
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.
Jacek Kubica, MD., PhD. principal investigator
Cardiology Department, Dr. A. Jurasz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crushed ticagrelor followed by morphine and Crushed ticagrelor, morphine,naloxone in people with Unstable Angina Pectoris, run by Collegium Medicum w Bydgoszczy 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 5 inclusion and 22 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: finished, as of the sponsor's last update on 1 Apr 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+naloxone arms (time frame: 6 hours). 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 1 Apr 2019.