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Screening Log�<Sheet2���������file:K:105. Mankato, MayoB. Study Tracking LogsScreening LogeREGULATORY BINDERC. Study Tracking Logs10. Screening LogTAILOR-PCI Screening Log.xlsxSheet1Sheet2Sheet3Sheet4YYZD1 = Male1=Yes1= Missed patient1. Yes, randomizedZ� 2 = Female 2= No PCI2= MD not supportiveQ2. Not randomized, Not suitable for revascularization based on angiography resultZ�J3=No: Subject not able to receive 12 months of dual anti-platelet theraphy3= Other (Specify))3. Not randomized, Failed attempt to PCI Z"4=No: Failure of index PCIZ-%4. Not randomized, Referred for CABG ZA95=No: Patient or physician refusal to enroll in the studyZ805. Not randomized , Other reason________________ZH@6=No: Patient with known CYP2C19 genotype prior to randomizationZ��7=No: Planned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure Z��8=No: Anticipated discontinuation of clopidogrel or ticagrelor within the 12 month follow up period, example for elective surgery ZJB9=No: Serum creatinine >2.5 mg/dL within 7 days of index procedureZ� �10=No: Platelet count <80,000 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3 within 7 days prior to index procedureZ3 +11= No: History of intracranial hemorrhage Z[ S12=No: Known hypersensitivity to clopidogrel or ticagrelor or any of its componentsZF >13=No: Inability to take aspirin at a dosage of 100 mg or lessZ� }14=No: Patient is participating in an investigational drug or device clinical trial that has not reached its primary endpointZ8015=No: Patient previously enrolled in this studyZ^V16=No: Patient is pregnant, lactating, or planning to become pregnant within 12 monthsZg_17=No: Patient has received an organ transplant or is on a waiting list for an organ transplantZum18=No: Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the procedureZ��19=No: Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous, etc.)Z�\20=No: Patient is receiving chronic (e"72 hours) vitamin K antagonist therapy (e.g. warfarin)ZD<�21=No: Concomitant use of simvastatin/lovastatin > 40 mg qd Z�22=No: Concomitant use of potent CYP3A4 inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital,Zyq23=No: Non-cardiac condition limiting life expectancy to less than one year, per physician judgment (e.g. cancer)Z9124=No: Known history of severe hepatic impairmentZld25=No: Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusionsZia26=No: Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleedingZME27=No: Current substance abuse (e.g., alcohol, cocaine, heroin, etc.)YY����! 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ELIGIBILITYE1E2YesE3000100020003000400050006000700080009001000110012001300140015001600170018001900200021002200230024002500260027002800290030003100320033003400350036003700380039004000410042004300440045004600470048004900500051005200530054005500560057005800590060006100620063006400650066006700680069007000710072007300740075007600770078007900800081008200830084008500860087008800890090009100920093009400950096009700980099010001010102010301040105010601070108010901100111011201130114011501160117011801190120012101220123012401250126012701280129013001310132013301340135013601370138013901400141014201430144014501460147014801490150015101520153015401550156015701580159016001610162016301640165016601670168016901700171017201730174017501760177017801790180018101820183018401850186018701880189019001910192019301940195019601970198019902000201020202030204020502060207020802090210021102120213021402150216021702180219022002210222022302240225022602270228022902300231023202330234023502360237023802390240024102420243024402450246024702480249025002510252025302540255025602570258025902600261026202630264026502660267026802690270027102720273027402750276027702780279028002810282028302840285028602870288028902900291029202930294029502960297029802990300030103020303030403050306030703080309031003110312031303140315031603170318031903200321032203230324032503260327032803290330033103320333033403350336033703380339034003410342034303440345034603470348034903500351035203530354035503560357035803590360036103620363036403650366036703680369037003710372037303740375037603770378037903800381038203830384038503860387038803890390039103920393039403950396039703980399040004010402040304040405040604070408040904100411041204130414041504160417041804190420042104220423042404250426042704280429043004310432043304340435043604370438043904400441044204430444044504460447044804490450045104520453045404550456045704580459046004610462,Screen Date dd-mmm-yyyy (last date screened) NoNo - patient refusedNo - patient diedNo - SDM refused No - other;Yes, Immediate RRT - life-threatening acid-base disturbance5Yes, Immediate RRT - life-threatening volume overload=Yes, Immediate RRT - life-threatening electrolyte abnormality7Yes, Immediate RRT - severe non-renal organ dysfunctionYes, Immediate RRT - Other5Yes, Deferral of RRT - no evidence of volume overload3Yes, Deferral of RRT - vascular access not feasible@Yes, Deferral of RRT - patient will soon recover kidney function@Yes, Deferral of RRT - clinical improvement in non-renal domainsYes, Deferral of RRT - Other5No - insurmountable language barrier (patient or SDM) Excluded due to Co- enrolment? <�Time Fully Eligible (24-hr clock HH:MM; n/a if not eligible)5Date Fully Eligible dd-mmm-yyyy (n/a if not eligible)I1I2I3I4I5<�Document ALL Inclusion & Exclusion criteria for each patient*No - patient unable to decide within 18hrs&No - SDM unable to decide within 18hrsEligibleYes - deferred consentYes - SDM provided consent"Yes - participant provided consent'No - no known SDM (no deferred consent)=No - unable to contact SDM within 18hrs (no deferred consent)3If excluded due to co-enrolment, specify study nameSubject Screening ID%Informed Consent at Time of ScreeningfRedCap Participant ID (for eligible, consented patients; assigned following randomization by database)Additional CommentsE40463046404650466046704680469047004710472047304740475047604770478047904800481048204830484048504860487048804890490049104920493049404950496049704980499050005010502050305040505050605070508050905100511051205130514051505160517051805190520052105220523052405250526052705280529053005310532053305340535053605370538053905400541054205430544054505460547054805490550055105520553055405550556055705580559056005610562056305640565056605670568056905700571057205730574057505760577057805790580058105820583058405850586058705880589059005910592059305940595059605970598059906000601060206030604060506060607060806090610061106120613061406150616061706180619062006210622062306240625062606270628062906300631063206330634063506360637version: 27Sep2024���$ %AO%y�%��%��%!/&Yg&��&��&'9G'q'��'��''(Q_(��(��(�)1?)iw)��)��)*IW*��*��*��*)7+ao+��+��+ ,AO,y�,��,��,!/-Yg-��-��- .9 G.q .� �.� �. '/Q _/� �/� �/� 01 ?0i w0� �0� �0 1I W1� �1� 2: u3�.5X�5�6$�7�8*88bp8��8��8 9BP9z�9��9��9"0:Zh:��:��:;:H;r€;��;��;(<R`<�cc��B����� ZO�� `€嘊3N{X胋 mSw泚銒+�s�华�K�撋塾A�设Q�冽a�  d褚MbP?_*+�€%�����&L&G Month: _____-______ &C&"Lucida Bright,Demibold"&14Screening and Enrolment Log &R Site #: ________________________________ Site Name: ________________________________ Site PI Name: ________________________________~{&L&"Arial,Italic"&9**Please complete information for all randomized patients in the Subject Identification Log**&R&8Page &P��&�?'�?(�?)�?M AXX�"AXX333333�?333333�?�&�<3U } € [} € [} [} €[}  [} * \} �\} � [} � ^} *`} � a} * €� @l@|�> ,€b€b€b€b€b€b €b €b €b €b €b€b€b€b€b€b€b€c€c€c€c€c€c€c€c€c€c€c€c���]]]]]]]v] � ��� ��� ��� �����������ddd � ��� ��� ��� ��� ��� ��� s�� s�� s�� s�� s�� t� t�  t�  t��  u��  u��  u�������� m�*nnnnnnnnnnnoonpqor� e�*fffffffffffggfhigk� e�*fffffffffffggfhigk� e �*fffffffffffggfhigk� e �*fffffffffffggfhigk� e �*fffffffffffggfhigk� e �* fffffffffffggfhigk� e �* 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