Cilostazol Aspirin Therapy Against Recurrent Stroke With by mikesanye


									                        Cilostazol-Aspirin Therapy Against Recurrent Stroke
                            With Intracranial Artery Stenosis (CATHARSIS)
Shinichiro Uchiyama, M.D. PhD.,1) Nobuyuki Sakai, M.D. PhD.,2) Yumi Kimura, M.D.,1) Masayuki Ezura, M.D. PhD.,3) Yasushi Okada, M.D. PhD.,4) Makoto Takagi, M.D. PhD.,5)
Youji Nagai, M.D. PhD.,6) Kazuo Minematsu, M.D. PhD.7) for the CATHARSIS Study Group        ClinicalTrials. gov Identifier : NCT00333164
1) Department of Neurology, Tokyo Women,s Medical University, 2) Department of Neurosurgery, Kobe City General Hospital, 3) Department of Neuroendovascular Therapy, Tohoku University, 4) Cerebrovascular center and Clinical Research
Institute, National Hospital Organization Kyushu Medical Center, 5) Department of Neurology, Saiseikai Central Hospital, 6) Translational Research Informatics Center, Kobe, 7) Cerebrovascular Division, National Cardiovascular Center

   Background                                                                                                            Fig.2 Grading of IAS

                                                                                                                             1 Normal : no evidence of stenosis
                                                                                                                             2 Mild stenosis : less than 50% stenosis
                                                                                                                             3 Moderate stenosis : more than 50% stenosis
                                                                                                                             4 Severe stenosis : partial signal loss with the distal flow signal
                                                                                                                             5 Occlusion : no distal flow signal

                                                                                                                                1                                   2                            3

                                                                                                                                4                                                                5

   Study Design

                                                                                                                                 Criteria for diagnosis of progression and improvement of IAS :
                                                                                                                                  One or more grades of change in IAS

                                                                                                                        Plan for Timing to Check Observation Items

                                                                                                                                                                      Pre-       Baseline                 Treatment period
                                                                                                                               Observation items                  registration     data                                            When stroke
                                                                                                                                                                                            3M       6M         12M          24M    occurred

   Patient Selection Criteria                                                                                                   Informed consent
                                                                                                                                      MRA scan
                                                                                                                                      MRI scan
                                                                                                                                 Medical history
                                                                                                                              History of medication
                                                                                                                              Serum biochemistry
                                                                                                                                    Follow-up visit
                                                                                                                         Death/cardiovascular events
                                                                                                                        (Stoke, MI, PAD, other vascular events)

                                                                                                                            Serious adverse events
                                                                                                                               Compliance check

                                                                                                                          Statistical Analyses

   Outcome Measure

                                                                                                                          Present Status



  Fig.1 Calculation method of stenosis rate on MRA
                b              a
                                                      Stenosis rate (%) = (b-a) / bx100
                                                      a : Vessel diameter of most stenotic portion
                                                      b : Normal vessel diameter

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