Frequently Asked Questions (FAQs)
Answers to frequently asked questions.

Randomisation
Q: How do I randomise a patient?
A: You can do it in one of two ways: 1) Enter that data on the form “Day 1” on www.scast.no. The computer will then allocate a drug pack number; 2) (If you don’t have access to the internet:) Use the drug pack with the lowest number. Remember to enter the data on the form “Day 1” as soon as you get the chance.
 
Obtaining of consent
Q: Can a patient be included without giving written consent?
A: Yes. There are three forms of “consent”: 1) Written consent; 2) Non-written consent (signature by witness); and 3) Assent by legal representative (signature by a proxy/relative).
 
“Exclusion” of patients who have already been included in the trial
Q: Can a patient be excluded from the trial?
A: No. All patients who have been included must be followed up according to the protocol (6 months). A patient should only be “excluded” if he / she express unwillingness to continue in the trial.
 
Treatment of non-eligible patient
Q: If a patient has been included that should not have been included: Should the patient be taken out of the trial?
A: No. All patients who have been given a drug pack number (from the central computer, via the internet) or who have been given tablets from a drug pack, must be followed according to the protocol (6 months).
 
Follow-up of a non-eligible patient
Q: If a patient has been included that should not have been included: Should the 7 days’ trial treatment be stopped?
A: No, not necessarily. If the patient has a stroke you should still given the treatment according to the protocol (unless you believe that this is not in the interest of the patient). If the patient was included without having a stroke you should stop the trial treatment. (Please remember that the patient must still be followed up according to the protocol.)
 
Treatment of severe and sustained blood pressure during the treatment period
Q: What can I do if a patient has severe and sustained blood pressure during the treatment period (e. g. > 230 mm Hg on day 5)?
A: You are free to use other antihypertensive drugs in addition to the trial treatment (see protocol, paragraph 8.4).
 
Documentation of serious averse events
Q: How should a serious adverse event be documented (e. g. a severe acute myocardial infarction)?
A: All serious SAEs should be recorded in the CRF for the following visit. For example, a myocardial infarction on day 20 should be recorded in the form “1 month”. Please include copies of other relevant documentation (ECG, medical records, etc.)
 
Unexpected serious adverse events
Q: What is an unexpected serious adverse event?
A: These are SAEs that are extra-ordinary during the course of a stroke, e. g. a rash, or elevation of liver enzymes. All events that are listed in the CRF (recurrent stroke, myocardial infarction, etc.) are “expected”. Some events are not listed, but must still be regarded as “expected”: confusion in elderly patients, hip fracture following a fall in a patients with dizziness, etc.
 
Reporting and documentation of unexpected serious adverse events
Q: How shall an unexpected serious adverse event be documented?
A: Please fill in the blue form on page 12 in the CRF and notify us within 24 hours of the event.
 
Economial compensation to patients
Q: Will SCAST cover patients’ expenses, and, if so, how will this be done?
A: SCAST will cover expenses that can not be covered by the public health system, and for which the patient asks for re-imbursement. We do not normally ask patients to hand in their receipts, - in most cases the expenses are covered by the patient himself/herself and/or the public health system. If you want SCAST to cover the expenses, we ask that the patient is first re-imbursed from your hospital. SCAST will pay the centre back once a year (in January). If the centre has no possibilities to cover the patient’s expenses temporarily, the patient’s receipts can be sent to the Trial Coordinating Centre with details about the patient’s bank account (IBAN-number and SWIFT-code).