Phase 4
N=74
Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Acute Myocardial Infarction
ST-segment Elevation Myocardial Infarction · Non-ST-segment Elevation Myocardial Infarction · VA Drug Interactions
Bottom Line
View on ClinicalTrials.gov: NCT02217878 ↗Enrolled (actual)
74
Serious AEs
4.3%
Results posted
Mar 2016
Primary outcome: Primary: Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h) — 6307; 9791 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug); Placebo (Drug); Ticagrelor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Collegium Medicum w Bydgoszczy
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h) |
6307; 9791 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h) |
1503; 2388 | — |
| SECONDARY Maximum Concentration of Ticagrelor |
1156; 1683 | — |
| SECONDARY Maximum Concentration of AR-C124910XX |
1085; 1043 | — |
| SECONDARY Time to Maximum Concentration for Ticagrelor |
4; 2 | — |
| SECONDARY Time to Maximum Concentration for AR-C124910XX |
4; 4 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h) |
2491; 5587 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6) |
472; 1001 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Reactivity Index Assessed by VASP Assay |
27.5; 15.6 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
19; 11 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY P2Y12 Reaction Units Assessed by VerifyNow |
9.0; 7.5 | — |
| SECONDARY Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP |
57; 29 | — |
| SECONDARY Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA |
40; 14 | — |
| SECONDARY Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow |
36; 19 | — |
| SECONDARY Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP |
2.0; 1 | — |
| SECONDARY Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA |
2.0; 1.0 | — |
| SECONDARY Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow |
1.0; 0.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- provision of informed consent prior to any study specific procedures
- diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
- male or non-pregnant female, aged 18-80 years old
- provision of informed consent for angiography and PCI
Exclusion Criteria
- chest pain described by the patient as unbearable or patient's request for analgesics
- prior morphine administration during the current STEMI or NSTEMI
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- hypersensitivity to ticagrelor
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
- history of intracranial hemorrhage
- 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)
- patients considered by the investigator to be at risk of bradycardic events
- second or third degree atrioventricular block during screening for eligibility
- history of asthma or severe chronic obstructive pulmonary disease
- patient required 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
Data sourced from ClinicalTrials.gov (NCT02217878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.