Presentation on theme: "Welcome to ACST-2! Guidance & Useful Information"— Presentation transcript:
1Welcome to ACST-2! Guidance & Useful Information ACST-2 OfficeLevel 6, Nuffield Department of Surgical SciencesUniversity of Oxford, John Radcliffe HospitalHeadley Way, OxfordOX3 9DU, UNITED KINGDOM
2ACST-2: Asymptomatic Carotid Surgery Trial –2 ACST-2 compares carotid endarterectomy and carotid stenting in patients with tight asymptomatic carotid stenosiscarotid surgery (CEA)orcarotid stenting (CAS)Primary outcomes to compare:-1) peri-procedural risks (MI, stroke & death) within 30 days after allocated intervention (CEA or CAS)2) compare long term benefits of stenting and surgeryAll patients are on optimal medical therapy, and patients can be enrolled in this study when the clinician is certain that an intervention is necessary and the both procedures are applicable, but is uncertain as to which procedure to choose.
3ACST-2 Background First patient randomised: 15/01/2008 Patients are now in their 6th year of follow up92 active centres from 27 countriesLargest (investigator-led) trial in the world comparing surgery vs. stenting in asymptomatic patients, having recruited >1,520Goal: recruit over 3,600 patients by the end of 2019Currently the peri-procedural stroke (fatal and disabling) and death within 30 days is 1.0 % in 1078 patients
4Clinician CTA MRA WHERE WE FIND TRIAL PATIENTS TIA/stroke clinicsStroke inpatientsClinicianDuplex DopplerCTA MRAPatient consent and entering in trialDETECTIONPatient eligibility discussed (e.g. MDT)Vascular outpatientsScreeningCardiology or cardiothoracic surgery assessmentWHERE WE FIND TRIAL PATIENTS
5Know the Inclusion Criteria Tight carotid artery stenosis (>70%), confirmed by duplex ultrasoundMRA/CTA shows that CEA and CAS are both practicableNo symptoms or signs* on the IPSILATERAL side for at least 6 monthsPatient is still eligible even if they’ve had a symptom or sign* on the CONTRALATERAL side within 6 monthsDoctor & patient are uncertain about whether to treat with CEA or CAS, but are certain an intervention is neededPatient is fit and willing for follow- up and is likely to live 5 to 10 years(*MR/CT infarcts)
6How to Randomise a patient in ACST-2 after informed consent. 1 How to Randomise a patient in ACST-2 after informed consent 1. Web randomisation 2. Phone randomisation
71. Web randomisation: Complete part 1 of the paper randomisation form Go to the ACST-2 Website and select the Web Randomisation tab select randomise a patientThen select ACST2 and Randomise a new patient
8Web randomisation cont. Select your country and centre from the drop down listSelect your name and enter your unique PIN (XXXXXX) from the drop down list and press ‘continue’Select the name of the Randomising Doctor (if this isn’t you)Then follow the instructions for on-line randomisationDon’t forget to return a copy of the fully completed paper randomisation form to the ACST-2 Office!If you are not the randomising doctor, then you will need to select the doctor’s name
92. Phone randomisation: Complete part 1 of the randomisation form Call +44 (0) (24 hour randomisation number)Give the randomisation team your PIN number and confirm your Hospital detailsThe randomisation team will then guide you through telephone randomisation. Please remember:-If you have any difficulties please call the ACST-2 office:orOr outside of office hours: +44 (0)
10Trial Documentation. 1. Site file. 2. Patient files 3 Trial Documentation 1. Site file 2. Patient files 3. ACST-2 study forms (CRF)
111. Site file ContentsContains all appropriate documentation according to GCP1. Protocol/ protocol amendments (deviations/violations)2. CRF3. Patient information and consent forms4. Investigator Section (agreements, finance, track records and MOI)5. Ethics and R&D (submission, approval & annual reports)6. Screening logs7. Delegation log and CV of PI8. Monitoring and Training9. Correspondence10. Note to fileEthics Annual report send us a copy
122. Patient files Set up patient files according to patient ID Original CRF (consent, randomisation & 1 Month Follow-up form) to be stored in patient fileCopy sent to ACST-2 officeAny correspondence with the patientMajor eventsFax a copy (+44 (0) or send a scanned copy via (removing any names of patients).
133. ACST-2 Study Forms Form Summary of data on Form Expected Return TimeConsent FormRecords informed consentUsually within 6 days after consenting patientRandomisation FormBaseline data, previous and current medical history, medications & allocated procedureUsually within 6 days after randomisation (Usually consent and randomisation forms are sent together)One Month Follow- up FormProcedure details, post procedure details (1 month after the procedure) & any Major Events.Usually within 8 weeks after randomisationAnnual Follow up FormLate strokes, other procedures and medication after one month follow-upAnnually – ACST-2 will send forms directly to collaborators or to patients.EQ-5D Form (only applicable in UK, Italy, Germany, Sweden & Belgium)Measures quality of life
14Consent and Randomisation forms Assuming you have the full copy of the 8 pages in the patient file (plus copy given to patient), you can send a copy of the patient information sheet and consent form.is also sent for confirmation of randomisationRandomisation form, part 1 is completed before randomisation. There is an option to complete part 2 online, but you can send it to us and we can enter it for you. Key point, that once you randomise you cant go back, check and double check all details for stratification . If you do make a randomisation error please contact us immediately.Any errors on the forms please continue with GCP, cross sign and date and if you think necessary put the reason for the errorConsent form. Give as many contact details as possible, clear and concise. It is not DOB , is is the date the informed consent took place and is to be the same date.
15Questions- Consent & Randomisation Forms Consent needs to be signed by patient and the doctor on the same day.Complete part 2 of the randomisation form either online (sending a copy of the paper form) or send a paper form to us to enter for you
16One Month formLike on randomisation form, uses Yes and NO not Crosses or ticks. Please complete all information. Seciton a refers to anything with procedural details. If the procedure is not done or a crossover is done, please always state the reason in the comments section
17Questions - One month follow up form Section B The duplex Doppler must be done Left and Right sides. Section E Don’t forget to complete the date for Current Status. Current therapy please be sure to select Yes or No to each box – do not use crosses or ticks or leave blank. Only complete page two of the One Month Follow-up Form if there is a major event.Some centres will only perform the ipsilateral side and the contralateral side can be used from the randomisation form if the procedure is done close enough to the time of randomisation.
18Common QueriesThe patient cannot have the procedure due to a medical reason.Please record why on the one month follow up form on Page 2 under ‘Any additional comments or information (as narrative)?If the patient does end up having the procedure later at anytime (even years later), please complete a new One month Follow up Form with all the procedural details and send this to the ACST-2 office.
19Common QueriesThe patient withdraws from the procedure but not from the trialPlease record this on the one month follow up form on Page 2 under ‘Any additional comments or information (as narrative)?Valuable information is provided even though the patient did not have the procedure.
20Common Queries A patient has a crossover due to a medical reason Please record why on the one month follow up form to note this on Page 2 under ‘Any additional comments or information (as narrative)?Then complete the rest of the form as per normal.
21Annual FU forms Sent by ACST-2 Office directly to the patient (unless otherwise agreed) Epcoh year 10 June 2014 – 10 June Please notify us of any strokes and deaths that you may know. Clear dosages, especially of statins. In addition, it is key that we capture Blood pressure, Anti-platelet, Anti-coagulant and LMD drugs in this section Any change in contact details. You will be contacted if there is a major event to collect more informationWhen will you be contacted? When there is a missing a missing Statin dose, a missing category of medication (AH, LMD, AP/AC) and a major event
22Common Queries- AF forms (rare) Major EventNormally we will contact the GP first or the patient again, but if needed we may ask you:1)Statins –dosage2) Why the patient is not on anti-hypertensive, lipid lowering medication or anti-platelet/anti-coagulant
23What are Major Events Stroke MI Death Peri-procedural events (<30 days) or late events (>30 days).The information required about these events that you will need to send:Stroke: CT/MRI scan , initial and 6 month modified Rankin scores, clinical notes (duration of symptoms and treatment)*MI: ECGs, Cardiac markers, clinical notesDeaths: Death certificate if available, cause of death, date of deathPlease report such events to as soon as possible (ideally within 1 week)* Only events within 30 days
24Missing formsAll missing forms are reported to the Data Monitoring Committee that meet Annually
25We are here to help!If you have any questions please contact us by or call +44 (0)