{
  "FullStudy":{
    "Rank":218197,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511471",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PATRASCARDIOLOGY-9"
          },
          "Organization":{
            "OrgFullName":"University of Patras",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis",
          "OfficialTitle":"Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 12, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 2, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 3, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Dimitrios Alexopoulos",
            "ResponsiblePartyInvestigatorTitle":"Clinical Professor",
            "ResponsiblePartyInvestigatorAffiliation":"University of Patras"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Patras",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Clopidogrel administration is commonly prescribed in patients undergoing percutaneous coronary intervention, in patients with previous stroke and in patients under chronic hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Ticagrelor is a new oral direct-acting antagonist, which provides greater platelet inhibition in both clopidogrel responders and non-responders. It has also been shown that in patients with chronic kidney disease (creatinine clearance <60 mL/min)ticagrelor achieved an absolute risk reduction of cardiovascular death, myocardial infarction, and stroke greater than that of patients with normal renal function. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily for 15 days. Platelet reactivity will be determined at the end of the treatment period. Bleeding events, major adverse cardiac events and any side effects until Day 15 will be reported in a descriptive manner."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Platelet Reactivity"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Ticagrelor",
              "platelet reactivity",
              "clopidogrel",
              "haemodialysis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Ticagrelor",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Ticagrelor 90mg twice a day for 15 days",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ticagrelor"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Ticagrelor",
                "InterventionDescription":"Ticagrelor 90mg twice a day for 15 days",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Ticagrelor"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Platelet reactivity assessed by VerifyNow P2Y12 assay",
                "PrimaryOutcomeTimeFrame":"Day 15"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Bleeding events according to TIMI criteria",
                "SecondaryOutcomeDescription":"Major, minor or minimal bleeding events according to TIMI criteria",
                "SecondaryOutcomeTimeFrame":"Day 15"
              },{
                "SecondaryOutcomeMeasure":"Major adverse cardiovascular events",
                "SecondaryOutcomeDescription":"Death, non-fatal myocardial infarction and stroke",
                "SecondaryOutcomeTimeFrame":"Day 15"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge≥18 years\nChronic renal failure under haemodialysis\nPlatelet reactivity under clopidogrel 75mgx1 ≥235 PRU\nInformed written consent\n\nExclusion Criteria:\n\nRecent (within 1 month) PCI or ACS\nRequirement for oral anticoagulant prior to the Day 14 visit\nPLTs<100.000 / μL), Hct <28%, Hct > 52% at randomization\nIncreased risk of bradycardiac events.\nSevere uncontrolled chronic obstructive pulmonary disease\nKnown severe hepatic impairment\nHistory of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.\nOther bleeding diathesis, or considered by investigator to be at high risk for bleeding\nConcomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer\nRecent (<6weeks)major surgery including CABG\nRecent (<6weeks)stroke or any prior intracranial bleeding",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"90 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Agios Andreas General Hospital, Nephrology Department",
                "LocationCity":"Patras",
                "LocationState":"Achaia",
                "LocationZip":"26500",
                "LocationCountry":"Greece"
              },{
                "LocationFacility":"Cardiology Department Patras University Hospital",
                "LocationCity":"Rio",
                "LocationState":"Achaia",
                "LocationZip":"26500",
                "LocationCountry":"Greece"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000077486",
                "InterventionMeshTerm":"Ticagrelor"
              }
            ]
          },
          "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":"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"
              }
            ]
          }
        }
      }
    }
  }
}