Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT03476369
Status:
TERMINATED
Last Update Posted:
2025-02-04
First Post:
2018-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Researcher stopped study due to slow accrual rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet Function Testing', 'timeFrame': '6 hours', 'description': 'Platelet vasodilator-stimulated phosphoprotein assay'}], 'secondaryOutcomes': [{'measure': 'Stent thrombosis', 'timeFrame': '30 days'}, {'measure': 'Recurrent myocardial infarction', 'timeFrame': '30 days'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days'}, {'measure': 'Stroke', 'timeFrame': '30 days'}, {'measure': 'TIMI minor and major', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'During a percutaneous coronary intervention (PCI), Fentanyl is commonly used for sedation. Ticagrelor is also routinely used as anti-platelet agent during PCI. However, a recent study has demonstrated the decrease in effectiveness of Ticagrelor when administered along with Fentanyl. Hence this study was designed to further assess the interaction between crushed vs non crushed Ticagrelor and Fentanyl given during PCI procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing clinically indicated elective or non-elective PCI\n* Able to swallow oral medications\n\nExclusion Criteria:\n\n* Contraindications to ticagrelor or fentanyl (or other opiates)\n* Pregnancy\n* Any use of P2Y12 inhibitors within 14 days\n* Known coagulation disorders\n* Pre-procedural treatment with an anticoagulant (oral anticoagulant or low molecular weight heparin)\n* Platelet count \\< 100,000/mm3\n* Impaired renal function (Estimated glomerular filtration \\< 45 ml/min/1.73 m2)\n* Impaired hepatic function (Based on medical history)\n* Prior or planned transcatheter aortic valve replacement'}, 'identificationModule': {'nctId': 'NCT03476369', 'acronym': 'FACTPCI', 'briefTitle': 'Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'The Guthrie Clinic'}, 'officialTitle': 'A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl', 'orgStudyIdInfo': {'id': '1801-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl and Crushed Ticagrelor', 'description': 'Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)', 'interventionNames': ['Drug: Fentanyl', 'Drug: Ticagrelor 90Mg Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl and Non-crushed Ticagrelor', 'description': 'Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)', 'interventionNames': ['Drug: Fentanyl', 'Drug: Ticagrelor 90Mg Tablet']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Premedicated with Fentanyl (at least 25mcg by IV)', 'armGroupLabels': ['Fentanyl and Crushed Ticagrelor', 'Fentanyl and Non-crushed Ticagrelor']}, {'name': 'Ticagrelor 90Mg Tablet', 'type': 'DRUG', 'description': 'Ticagrelor administered crushed vs non-crushed', 'armGroupLabels': ['Fentanyl and Crushed Ticagrelor', 'Fentanyl and Non-crushed Ticagrelor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Guthrie Clinic', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Guthrie Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}