Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-04-23 @ 9:03 PM
Study NCT ID:
NCT02939235
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2016-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Metoclopramide on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D008787', 'term': 'Metoclopramide'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+metoclopramide arms', 'timeFrame': '6 hours'}], 'secondaryOutcomes': [{'measure': 'Maximum ticagrelor and AR-C124900XX concentration at 6h after administration (Cmax6)', 'timeFrame': '6 hours'}, {'measure': 'Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)', 'timeFrame': 'prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose'}, {'measure': 'Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)', 'timeFrame': 'prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose'}, {'measure': 'Platelet arbitrary aggregation units/min assessed by Multiple Electrode Aggregometry', 'timeFrame': 'prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unstable Angina Pectoris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite between patients who received ticagrelor and morphine followed by metoclopramide versus patients treated with ticagrelor and morphine alone for unstable angina pectoris.', 'detailedDescription': '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.\n\nTaking 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 metoclopramide or 2) intravenous morphine alone.\n\nThe 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.\n\nPlatelet reactivity will be assessed with the Multiplate Analyzer in all study participants at nine predefined time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Diagnosis of unstable angina\n* Male or non-pregnant female, aged 18-80 years\n* Provision of informed consent for angiography and PCI\n* GRACE score \\<140 pts\n\nExclusion Criteria:\n\n* treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment\n* current treatment with morphine or any opioid "mi" receptor agonist\n* hypersensitivity to ticagrelor\n* current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin\n* active bleeding\n* history of intracranial hemorrhage\n* recent gastrointestinal bleeding (within 30 days)\n* history of coagulation disorders\n* platelet count less than \\<100 x10\\^3/mcl\n* hemoglobin concentration less than 10.0 g/dl\n* history of moderate or severe hepatic impairment\n* history of major surgery or severe trauma (within 3 months)\n* risk of bradycardic events as judged by the investigator\n* second or third degree atrioventricular block during screening for eligibility\n* history of asthma or severe chronic obstructive pulmonary disease\n* kidney disease requiring dialysis\n* manifest infection or inflammatory state\n* Killip class III or IV during screening for eligibility\n* respiratory failure\n* history of severe chronic heart failure (NYHA class III or IV)\n* 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\n* body weight below 50 kg'}, 'identificationModule': {'nctId': 'NCT02939235', 'briefTitle': 'Influence of Metoclopramide on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine', 'organization': {'class': 'OTHER', 'fullName': 'Collegium Medicum w Bydgoszczy'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CMUMK202F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Crushed ticagrelor followed by morphine', 'description': 'crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously', 'interventionNames': ['Drug: Crushed ticagrelor followed by morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crushed ticagrelor, morphine,metoclopramide', 'description': 'crushed ticagrelor 180 mg administered orally followed by morphine 5 mg and metoclopramide 10 mg intravenously', 'interventionNames': ['Drug: Crushed ticagrelor, morphine,metoclopramide']}], 'interventions': [{'name': 'Crushed ticagrelor followed by morphine', 'type': 'DRUG', 'otherNames': ['Brilique'], 'description': 'Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously', 'armGroupLabels': ['Crushed ticagrelor followed by morphine']}, {'name': 'Crushed ticagrelor, morphine,metoclopramide', 'type': 'DRUG', 'otherNames': ['Brilique'], 'description': 'Crushed ticagrelor (180 mg) orally followed by morphine 5 mg and metoclopramide 10 mg intravenously', 'armGroupLabels': ['Crushed ticagrelor, morphine,metoclopramide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-094', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Cardiology Department, Dr. A. Jurasz University Hospital', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Jacek Kubica, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Department, Dr. A. Jurasz University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collegium Medicum w Bydgoszczy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Jacek Kubica, MD, PhD', 'investigatorFullName': 'Jacek Kubica', 'investigatorAffiliation': 'Collegium Medicum w Bydgoszczy'}}}}