Informed Consent Form Version number 1.0 June 2006
THIS SHEET HAS BEEN APPROVED BY THE WEST ETHICS COMMITTEE INFORMATION SHEET FOR PATIENTS/VOLUNTEERS IN CLINICAL RESEARCH PROJECT
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide
whether or not you wish to take part.
Thank you for reading this.
Brief Title of Project
Platelet inhibition in patients following stent thrombosis.
What does this title mean?
When patients have stents placed in coronary arteries (Percutaneous Coronary Intervention, PCI) we give aspirin and another similar medication called clopidogrel (antiplatelet therapy) to help prevent clots forming and the stents suddenly blocking. Despite this, a small number of stents still block off (stent thrombosis.) This may be due to resistance to the effects of these therapies.
What is the purpose of the study?
We now have special tests that can measure how well aspirin and clopidogrel are preventing the formation of blood clots. The purpose of this study is to establish whether, in patients who have suddenly blocked a stent, there is a reduced effect of aspirin and clopidogrel.
Our hope is that if we can demonstrate that patients who suffer stent thrombosis have a reduced response to antiplatelet therapy, we may be able to alter their medication to help prevent this complication in the future.
Why have I been chosen?
Page | 224 You have been chosen to take part in this study because you have previously had a stent
placed in your heart arteries and this stent suddenly blocked. We intend to recruit all local patients who have had this complication.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.
What will happen to me if I take part?
If you are interested in taking part, we will assess your suitability by means of a review of your case notes and previous investigations at the time of your attendance at clinic or whilst on the ward. You will then be asked to read this information leaflet and be given time to decide whether you wish to take part in the study.
All patients who agree to take part in the study, after providing their written consent, will have a full medical history taken, including all medications. They will also undergo a brief physical examination. This should take no more than 15 minutes.
Patients who agree to take part in the study will have a simple blood test carried out. Blood samples (approximately 2 tablespoons) will be drawn from the arm and should cause no more than a small jagging sensation.
Following this we will thank you for your participation in the study and nothing else shall be required to be done.
This study does not involve any experimental treatment, there are no restrictions to your lifestyle, and you should continue to live as you normally would.
What are the side effects of any treatment received when taking part?
There are no additional treatments given as part of this study.
What are the potential risks or disadvantages to me if I have these tests performed?
Having your blood taken is occasionally uncomfortable and some people may feel faint.
There is a small risk of bleeding, bruising or infection at the puncture site following the blood test.
What are the possible benefits of taking part in this study?
Page | 225 You may not benefit directly from taking part in the study, however the information that we get from this study may help us to improve the treatment of future patients undergoing PCI and may help prevent heart attacks and strokes.
You will not be paid for taking part in this study.
What happens if new information becomes available?
Sometimes during the course of a research project, new information becomes available about the condition being studied. If this happens, your research doctor will tell you about it and discuss with you whether you want to continue in the study, or whether it might be in your best interest to withdraw, or be withdrawn from the study.
What if something goes wrong?
If you are harmed as a result of taking part in this study, there are no special compensation arrangements. If you are harmed as a result of someone’s negligence, then you may have grounds for legal action, but you may have to pay for it.
If you wish to complain, or have any concerns about the way you have been treated during the course of this study, the normal National Health Service complaints mechanisms will be available to you.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason.
A decision to withdraw at any time, or a decision not to take part, will not affect your medical care in any way, either now, or in the future.
If you are, or are likely to become, pregnant you should not participate in the study.
Will my taking part in this study be kept confidential?
All information which is collected during the course of the research will be kept strictly confidential. Any information which leaves the hospital/surgery will have your name and address removed so that you cannot be recognised from it.
What will happen to the results of the research study?
When the final results become available, they will be submitted to medical journals (magazines) where they will be considered for publication. The final results will also be submitted to national and international medical conferences, where they will be considered for presentation.
If you would like a copy of the results, please ask your study doctor.
Who is organising and funding the research?
Page | 226 This research has been sponsored by the West Research Endowments Fund. The medical staff receive no payment for including you in the study.
Who has reviewed the study?
This study has been reviewed by the local Research Ethics Committee. More details can be provided, on request, by your study doctor.
Who can I contact to get more information about this study?
You are encouraged to ask questions at any time during the study.
Please contact:-
Study Doctor: Dr Richard IS Good
Cardiology Research Unit 0141-211 6390 Supervisor: Dr Keith G Oldroyd 0141 211 2337 Independent Doctor: Dr Stephen D Robb 0141 211 1903 Thank you for taking the time to read this patient information leaflet.
You should be given a copy of this and the signed consent form to keep.
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