Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT04790032
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117446', 'term': 'cangrelor'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-06', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l', 'timeFrame': '30 minutes', 'description': 'Platelet inhibition assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop'}], 'secondaryOutcomes': [{'measure': 'Maximum platelet aggregation (MPA) with LTA-ADP 20 µmol/l', 'timeFrame': '30 minutes', 'description': 'Platelet aggregation assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop'}, {'measure': 'Rates of High Residual Platelet Reactivity (HRPR) with LTA-ADP 20 µmol/l defined as MPA>59%', 'timeFrame': '30 minutes', 'description': 'High platelet aggregation assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop'}, {'measure': 'Inhibition of platelet activity (IPA, %) with LTA-ADP 5 µmol/l', 'timeFrame': '30 minutes', 'description': 'Platelet inhibition assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop'}, {'measure': 'Maximum platelet aggregation (MPA) with LTA-ADP 5 µmol/l', 'timeFrame': '30 minutes', 'description': 'Platelet aggregation assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop'}, {'measure': 'Rates of High Residual Platelet Reactivity with LTA-ADP 5 µmol/l defined as MPA>46%', 'timeFrame': '30 minutes', 'description': 'High platelet aggregation assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop'}, {'measure': 'Area under the curve (AUC) at Multiplate with ADP test', 'timeFrame': '30 minutes', 'description': 'Platelet aggregation assessed with Multiplate ADP test at 30 minutes and after infusion stop'}, {'measure': 'Rates of HRPR defined as Multiplate AUC >46 U', 'timeFrame': '30 minutes', 'description': 'High platelet aggregation assessed with Multiplate ADP test at 30 minutes and after infusion stop'}, {'measure': 'P2Y12 Reaction Unit (PRU) at VerifyNow', 'timeFrame': '30 minutes', 'description': 'Platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop'}, {'measure': 'Rates of HRPR defined as VerifyNow PRU >208', 'timeFrame': '30 minutes', 'description': 'High platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop'}, {'measure': 'Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow', 'timeFrame': 'After stop of cangrelor infusion', 'description': 'Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow few hours after cangrelor infusion interruption'}, {'measure': 'Clinical outcomes at 30 days', 'timeFrame': '30 day', 'description': 'Ischemic and bleeding outcomes at 30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cangrelor', 'Acute coronary syndrome', 'Chronic coronary syndrome'], 'conditions': ['Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'pmid': '32795098', 'type': 'BACKGROUND', 'citation': 'Gargiulo G, Esposito G, Avvedimento M, Nagler M, Minuz P, Campo G, Gragnano F, Manavifar N, Piccolo R, Tebaldi M, Cirillo P, Hunziker L, Vranckx P, Leonardi S, Heg D, Windecker S, Valgimigli M. Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial. Circulation. 2020 Aug 4;142(5):441-454. doi: 10.1161/CIRCULATIONAHA.120.046928. Epub 2020 Jun 27.'}, {'pmid': '31202949', 'type': 'BACKGROUND', 'citation': 'Sibbing D, Aradi D, Alexopoulos D, Ten Berg J, Bhatt DL, Bonello L, Collet JP, Cuisset T, Franchi F, Gross L, Gurbel P, Jeong YH, Mehran R, Moliterno DJ, Neumann FJ, Pereira NL, Price MJ, Sabatine MS, So DYF, Stone GW, Storey RF, Tantry U, Trenk D, Valgimigli M, Waksman R, Angiolillo DJ. Updated Expert Consensus Statement on Platelet Function and Genetic Testing for Guiding P2Y12 Receptor Inhibitor Treatment in Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1521-1537. doi: 10.1016/j.jcin.2019.03.034. Epub 2019 Jun 12.'}, {'pmid': '29084738', 'type': 'BACKGROUND', 'citation': 'Angiolillo DJ, Rollini F, Storey RF, Bhatt DL, James S, Schneider DJ, Sibbing D, So DYF, Trenk D, Alexopoulos D, Gurbel PA, Hochholzer W, De Luca L, Bonello L, Aradi D, Cuisset T, Tantry US, Wang TY, Valgimigli M, Waksman R, Mehran R, Montalescot G, Franchi F, Price MJ. International Expert Consensus on Switching Platelet P2Y12 Receptor-Inhibiting Therapies. Circulation. 2017 Nov 14;136(20):1955-1975. doi: 10.1161/CIRCULATIONAHA.117.031164. Epub 2017 Oct 30.'}, {'pmid': '40375762', 'type': 'RESULT', 'citation': 'Gargiulo G, Cirillo P, Sperandeo L, Castiello DS, Manzi L, Forzano I, Florimonte D, Simonetti F, Canonico ME, Avvedimento M, Paolillo R, Spinelli A, Buongiorno F, Serafino LD, Spaccarotella CAM, Franzone A, Piccolo R, Stabile E, Valgimigli M, Esposito G. Pharmacodynamic effects of cangrelor in patients with acute or chronic coronary syndrome undergoing percutaneous coronary intervention: the POMPEII Registry. EuroIntervention. 2025 May 16;21(10):560-570. doi: 10.4244/EIJ-D-24-00757.'}]}, 'descriptionModule': {'briefSummary': 'This prospective registry was designed to carefully investigate the pharmacodynamic (PD) effects of cangrelor in all patients undergoing percutaneous coronary intervention (PCI).', 'detailedDescription': 'There is huge interest in achieving fast and immediate antiplatelet effect at the time of PCI, particularly in acute myocardial infarction and Cangrelor is an intravenous antagonist of the P2Y12 receptor characterized by rapid, potent, predictable, and reversible platelet inhibition. However, there are limited pharmacodynamic data exploring the effects of this drug in the various clinical settings at the approved dosages and with current gold standard methods for testing platelet reactivity. More importantly, there are no data on rates and predictors of high residual platelet reactivity (HRPR) in patients treated with cangrelor. Therefore the present study aims at building up a large prospective registry of pharmacodynamic data obtained by light transmittance aggregometry (LTA), multiplate analysis and verifynow system in patients undergoing PCI and receiving cangrelor.\n\nThis study is designed as a single-center prospective registry. Investigators at University Hospital of Naples Federico II will enroll patients, collect blood samples, perform platelet function tests and collect clinical and demographic information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with Acute (ACS) or Chronic coronary syndrome (CCS) undergoing PCI and receiving cangrelor administration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients undergoing PCI and receiving cangrelor administration will be eligible for inclusion in the study.\n\nExclusion Criteria:\n\n* only those not providing consent to blood/data collection will be excluded.'}, 'identificationModule': {'nctId': 'NCT04790032', 'acronym': 'POMPEII', 'briefTitle': 'Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'PharmacOdynaMic Effects of Cangrelor in PatiEnts wIth Acute or chronIc Coronary Syndrome Undergoing Percutaneous Coronary Intervention (POMPEII Registry)', 'orgStudyIdInfo': {'id': 'POMPEII Registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cangrelor', 'type': 'DRUG', 'description': 'All patients receiving Cangrelor during PCI will be enrolled and analyzed for platelet function tests.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'University Federico II of Naples', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Giuseppe Gargiulo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy'}, {'name': 'Giovanni Esposito, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Giuseppe Gargiulo', 'investigatorAffiliation': 'Federico II University'}}}}