please speak to your doctor or call - the wright center · 210647 brochure v2.0 na (english)...

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210647 Brochure v2.0 NA (English) 29.Apr.13 Are you Eligible? Please speak to your doctor or call:

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Page 1: Please speak to your doctor or call - The Wright Center · 210647 Brochure v2.0 NA (English) 29.Apr.13 Are you Eligi le? Please speak to your doctor or call:

210647 Brochure v2.0 NA (English) 29.Apr.13

Are you Eligible? Please speak to your doctor or call:

Page 2: Please speak to your doctor or call - The Wright Center · 210647 Brochure v2.0 NA (English) 29.Apr.13 Are you Eligi le? Please speak to your doctor or call:

What is the purpose of this clinical trial?This clinical trial will be looking at an investigational anticoagulant (blood thinning) medication in patients undergoing Percutaneous Coronary Intervention Procedure (PCI). Anticoagulants are given to thin the blood during the PCI procedure.

What is a clinical Trial? • Aclinicaltrialisaresearchstudy

conducted to help answer specific health questions and look at new ways to treat patients

• Comparesaninvestigationaldrugwithexisting medicines or treatments to determine which is better

• Answerquestionsaboutthesafetyandtheeffectivenessofmedicaltreatments

Why participate in a Clinical Trial? Participation in a clinical trial is voluntary and allows people to actively participate in researching potential new treatments. Clinical Trials may not directly benefit you.However,theinformationcollectedfromaresearchstudycanprovidemoreinformationontreatmentforpatientswiththesameconditioninthefuture.

Is there a cost to participate?There is no additional cost to you or your insurance company to participate in this clinical trial. The study drug and the tests andproceduresthatwillbedoneonlyforthestudywillbepaidforbystudyfunds.Thecostofyourroutinemedicalcarewillbe billed to you or to your health insurance company in the usual way.

What happens next?Ifyouwouldlikeadditionalinformationabout participating in the REGULATE-PCI study, please ask your doctor or contact the research study team.

If I agree to participate, what will I need to do?Ifyouagreetoparticipateinthisresearchstudy, the study doctor will review the detailsofthestudyandansweranyquestionsthatyoumayhave.Ifyouagreeto participate, you will read and sign a consentformandhaveyourscheduledangiogram.Ifitisdeterminedthatyouwill require a PCI, you will be enrolled inthestudyandwillreceive1of2studytreatment options. Additional blood sampleswillbedrawnforthestudyandinformationaboutyou,yourprocedure,and your recovery will be collected. The studyteamwillfollowyourprogresscloselyandcontactyouabout3daysafteryourPCI to see how you are doing. They will also contact you by phone approximately 30daysafteryourPCIandcheckonyourstatusat6months.Afterthe6monthstatus check, your participation in the study willbecompleteandnoadditionalfollow-up with the study team will be required.