Influence of Metoclopramide on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02939235
• Date of registration: 18/10/2016
• Prospective Registration: No
• Primary sponsor: Collegium Medicum w Bydgoszczy
• Public title: Influence of Metoclopramide on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine
• Scientific 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 Metoclopramide or Morphine Alone - a Randomized Study
• Date of first enrolment: July 2016
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02939235
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Poland

Contacts

• Name: Jacek Kubica, MD., PhD.
• Affiliation: Cardiology Department, Dr. A. Jurasz University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Provision of informed consent prior to any study specific procedures

- Diagnosis of unstable angina

- Male or non-pregnant female, aged 18-80 years

- Provision of informed consent for angiography and PCI

- GRACE score <140 pts

Exclusion Criteria:

- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before
the study enrollment

- current treatment with morphine or any opioid "mi" receptor agonist

- 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)

- risk of bradycardic events as judged by the investigator

- second or third degree atrioventricular block during screening for eligibility

- history of asthma or severe chronic obstructive pulmonary disease

- kidney disease requiring 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

Unstable Angina Pectoris

Intervention(s)

Drug: Crushed ticagrelor followed by morphine

Drug: Crushed ticagrelor, morphine,metoclopramide

Primary Outcome(s)

Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+metoclopramide arms [Time Frame: 6 hours]

Secondary Outcome(s)

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]

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]

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]

Maximum ticagrelor and AR-C124900XX concentration at 6h after administration (Cmax6) [Time Frame: 6 hours]

Secondary ID(s)

CMUMK202F

Source(s) of Monetary Support

Please refer to primary and secondary sponsors