Influence of Naloxone on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine
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|ClinicalTrials.gov Identifier: NCT02939248|
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Unstable Angina Pectoris||Drug: Crushed ticagrelor followed by morphine Drug: Crushed ticagrelor, morphine,naloxone||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Active Comparator: Crushed ticagrelor followed by morphine
crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously
Drug: Crushed ticagrelor followed by morphine
Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously
Other Name: Brilique
Active Comparator: Crushed ticagrelor, morphine,naloxone
crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously and naloxone 1 mg orally
Drug: Crushed ticagrelor, morphine,naloxone
Crushed ticagrelor (180 mg) orally followed by morphine 5 mg intravenously and naloxone 1 mg orally
Other Name: Brilique
- Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+naloxone arms [ Time Frame: 6 hours ]
- 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 ]
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): NCT02939248
|Cardiology Department, Dr. A. Jurasz University Hospital|
|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-094|
|Principal Investigator:||Jacek Kubica, MD., PhD.||Cardiology Department, Dr. A. Jurasz University Hospital|