A Phase 4 interventional study of Crushed ticagrelor followed by morphine and Crushed ticagrelor, morphine,metoclopramide in Unstable Angina Pectoris, sponsored by Collegium Medicum w Bydgoszczy. Completed at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-01.
Sponsored by Collegium Medicum w Bydgoszczy · Phase 4, Interventional, and Treatment
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 metoclopramide versus patients treated with ticagrelor and morphine alone for unstable angina pectoris.
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 metoclopramide 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.
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's enrollment of 32 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Collegium Medicum w Bydgoszczy is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously
Drug: Crushed ticagrelor followed by morphine
crushed ticagrelor 180 mg administered orally followed by morphine 5 mg and metoclopramide 10 mg intravenously
Drug: Crushed ticagrelor, morphine,metoclopramide
Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously
Also known as: Brilique
Crushed ticagrelor (180 mg) orally followed by morphine 5 mg and metoclopramide 10 mg intravenously
Also known as: Brilique
Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+metoclopramide arms
Time frame: 6 hours
Maximum ticagrelor and AR-C124900XX concentration at 6h after administration (Cmax6)
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
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Collegium Medicum w Bydgoszczy