{ "FullStudy":{ "Rank":218295, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510171", "OrgStudyIdInfo":{ "OrgStudyId":"RAPID" }, "Organization":{ "OrgFullName":"Careggi Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Rapid Activity of Platelet Inhibitor Drugs Study", "OfficialTitle":"Rapid Activity of Platelet Inhibitor Drugs Study", "Acronym":"RAPID" }, "StatusModule":{ "StatusVerifiedDate":"September 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 13, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 24, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 25, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"David Antoniucci", "ResponsiblePartyInvestigatorTitle":"Head Division of Invasive Cardiology", "ResponsiblePartyInvestigatorAffiliation":"Careggi Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Careggi Hospital", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with bivalirudin monotherapy.", "DetailedDescription":"Fifty consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be randomized to receive 60 mg Prasugrel loading dose (n= 25) or 180 Ticagrelor loading dose (n= 25) before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered. All interventions will be performed by the femoral approach according to current standards. The use of thrombectomy before infarct-related artery stenting, of everolimus eluting stent and of closure devices will be strongly encouraged. Bivalirudin will be administered as a bolus 0.75 mg/kg followed by 1.75 mg/kg/h infusion during PCI. After PCI a reduced bivalirudin infusion of 0.25 mg/kg/h for 4 hours will be allowed. Dual antiplatelet therapy (100 mg aspirin associated with 5 or 10 mg Prasugrel or 180 mg Ticagrelor) will be recommended for 12 months.\n\nResidual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2, 4, 8 and 12 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit. High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow. At the same time point, Activated Clotting Time (ACT) will be also assessed. Follow-up will be performed by outpatient visits or telephone interviews at 6 months." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "ST-segment Elevation Myocardial Infarction" ] }, "KeywordList":{ "Keyword":[ "platelet inhibitor", "ST-segment elevation myocardial infarction", "stent", "prasugrel", "ticagrelor" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Prasugrel loading dose", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Prasugrel" ] } },{ "ArmGroupLabel":"Ticagrelor Loading dose", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Ticagrelor" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Prasugrel", "InterventionDescription":"25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 60 mg Prasugrel loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Prasugrel loading dose" ] } },{ "InterventionType":"Drug", "InterventionName":"Ticagrelor", "InterventionDescription":"25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 180 Ticagrelor loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ticagrelor Loading dose" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Residual platelet reactivity by VerifyNow", "PrimaryOutcomeDescription":"Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit.", "PrimaryOutcomeTimeFrame":"2 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"High residual platelet reactivity", "SecondaryOutcomeDescription":"High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow.", "SecondaryOutcomeTimeFrame":"2,4,8,12 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients presenting within 12 hours from the onset of symptoms with STEMI\nInformed, written consent\n\nExclusion Criteria:\n\nAge < 18 years\nActive bleeding; bleeding diathesis; coagulopathy\nHistory of gastrointestinal or genitourinary bleeding <2 months\nMajor surgery in the last 6 weeks\nHistory of intracranial bleeding or structural abnormalities\nSuspected aortic dissection\nAny previous TIA/stroke\nAdministration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, GPI.\nKnown relevant hematological deviations: Hb <10 g/dl, Platelet count <100x10^9/l\nUse of coumadin derivatives within the last 7 days\nChronic therapy with prasugrel or ticagrelor\nKnown malignancies or other comorbid conditions with life expectancy <1 year\nKnown severe liver disease, severe renal failure\nKnown allergy to the study medications\nPregnancy", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"David Antoniucci, MD", "OverallOfficialAffiliation":"Careggi Hospital, Division of Invasive Cardiology", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Careggi Hospital", "LocationCity":"Florence", "LocationZip":"50134", "LocationCountry":"Italy" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"23500251", "ReferenceType":"derived", "ReferenceCitation":"Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077486", "InterventionMeshTerm":"Ticagrelor" },{ "InterventionMeshId":"D000068799", "InterventionMeshTerm":"Prasugrel Hydrochloride" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000010975", "InterventionAncestorTerm":"Platelet Aggregation Inhibitors" },{ "InterventionAncestorId":"D000058921", "InterventionAncestorTerm":"Purinergic P2Y Receptor Antagonists" },{ "InterventionAncestorId":"D000058919", "InterventionAncestorTerm":"Purinergic P2 Receptor Antagonists" },{ "InterventionAncestorId":"D000058914", "InterventionAncestorTerm":"Purinergic Antagonists" },{ "InterventionAncestorId":"D000058905", "InterventionAncestorTerm":"Purinergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1812", "InterventionBrowseLeafName":"Ticagrelor", "InterventionBrowseLeafAsFound":"Ticagrelor", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M310", "InterventionBrowseLeafName":"Prasugrel Hydrochloride", "InterventionBrowseLeafAsFound":"Prasugrel", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M12448", "InterventionBrowseLeafName":"Platelet Aggregation Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27881", "InterventionBrowseLeafName":"Purinergic P2Y Receptor Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"PlAggInh", "InterventionBrowseBranchName":"Platelet Aggregation Inhibitors" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009203", "ConditionMeshTerm":"Myocardial Infarction" },{ "ConditionMeshId":"D000072657", "ConditionMeshTerm":"ST Elevation Myocardial Infarction" },{ "ConditionMeshId":"D000007238", "ConditionMeshTerm":"Infarction" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007511", "ConditionAncestorTerm":"Ischemia" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000009336", "ConditionAncestorTerm":"Necrosis" },{ "ConditionAncestorId":"D000017202", "ConditionAncestorTerm":"Myocardial Ischemia" },{ "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10738", "ConditionBrowseLeafName":"Myocardial Infarction", "ConditionBrowseLeafAsFound":"Myocardial Infarction", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8865", "ConditionBrowseLeafName":"Infarction", "ConditionBrowseLeafAsFound":"Infarction", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M1072", "ConditionBrowseLeafName":"ST Elevation Myocardial Infarction", "ConditionBrowseLeafAsFound":"ST-segment Elevation Myocardial Infarction", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10867", "ConditionBrowseLeafName":"Necrosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5129", "ConditionBrowseLeafName":"Coronary Artery Disease", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18089", "ConditionBrowseLeafName":"Myocardial Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }