Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Acute Myocardial Infarction

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02217878
• Date of registration: 14/08/2014
• Prospective Registration: No
• Primary sponsor: Collegium Medicum w Bydgoszczy
• Public title: Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Acute Myocardial Infarction IMPRESSION
• Scientific title: 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.
• Date of first enrolment: August 2014
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02217878
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Poland

Contacts

• Name: Prof. Jacek Kubica, MD, PhD
• Affiliation: Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikolaja Kopernika w Toruniu

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

ST-segment Elevation Myocardial Infarction

VA Drug Interactions

Non-ST-segment Elevation Myocardial Infarction

Intervention(s)

Drug: Morphine

Drug: Ticagrelor

Drug: Placebo

Primary Outcome(s)

Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h) [Time Frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose]

Secondary Outcome(s)

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: 30 minutes post ticagrelor dose]

Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h) [Time Frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: 30 minutes post ticagrelor dose]

Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP [Time Frame: 2 hours]

Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h) [Time Frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose]

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: 1 hour post ticagrelor dose]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: 1 hour post ticagrelor dose]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: 12 hours post ticagrelor dose]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: 1 hour post ticagrelor dose]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: 3 hours post ticagrelor dose]

Maximum Concentration of Ticagrelor [Time Frame: 12 hours]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: 2 hours post ticagrelor dose]

Time to Maximum Concentration for Ticagrelor [Time Frame: 12 hours]

Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP [Time Frame: 12 hours]

Maximum Concentration of AR-C124910XX [Time Frame: 12 hours]

Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA [Time Frame: 2 hours]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: 4 hours post ticagrelor dose]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: 6 hours post ticagrelor dose]

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: 2 hours post ticagrelor dose]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: 3 hours post ticagrelor dose]

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: 4 hours post ticagrelor dose]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: 30 minutes post ticagrelor dose]

Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow [Time Frame: 2 hours]

P2Y12 Reaction Units Assessed by VerifyNow [Time Frame: prior to the initial ticagrelor dose]

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: 12 hours post ticagrelor dose]

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: 6 hours post ticagrelor dose]

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: prior to the initial ticagrelor dose]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: 2 hours post ticagrelor dose]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: 4 hours post ticagrelor dose]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: 12 hours post ticagrelor dose]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: prior to the initial ticagrelor dose]

Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow [Time Frame: 12 hours]

Platelet Reactivity Index Assessed by VASP Assay [Time Frame: 6 hours post ticagrelor dose]

Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6) [Time Frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose]

Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry [Time Frame: 3 hours post ticagrelor dose]

Time to Maximum Concentration for AR-C124910XX [Time Frame: 12 hours]

Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA [Time Frame: 12 hours]

Secondary ID(s)

CMUMK202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02217878