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A Randomized, Double-blind Study Evaluating the Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor and Its Active Metabolite (AR-C124910XX) in Patients With ST-segment Elevation Myocardial Infarction and Non-ST-segment Elevation Myocardial Infarction. (IMPRESSION)
The purpose of the IMPRESSION study is to determine whether intravenous administration of morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction (STEMI) patients and in non-ST-segment elevation myocardial infarction (NSTEMI) patients alters the plasma concentrations of ticagrelor and its active metabolite and whether it is associated with any negative impact on the antiplatelet effect of ticagrelor.
Details
| Lead sponsor | Collegium Medicum w Bydgoszczy |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 74 |
| Start date | 2014-08 |
| Completion | 2015-06 |
Conditions
- ST-segment Elevation Myocardial Infarction
- Non-ST-segment Elevation Myocardial Infarction
- VA Drug Interactions
Interventions
- Morphine
- Placebo
- Ticagrelor
Primary outcomes
- Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h) — prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose
Countries
Poland