Eligibility

Co-enrolment with PLACEMENT is permitted.
Additional co-enrolment may be allowed, however, this need to be checked with the study team first.
Please contact the research nurse team on cuh.rdt@nhs.net or via secure chat Research Delivery Team to facilitate.

Adults (aged 18 years and over) undergoing percutaneous or hybrid endovascular intervention for chronic limb threatening ischaemia [CLTI] of the lower limbs
Atherosclerosis as the cause of CLTI
Target arteries: infrainguinal (common femoral to pedal) if percutaneous, or iliac to pedal if performed as part of hybrid revascularisation with common femoral endarterectomy or when the iliac artery is not treated in isolation percutaneously
Clinicians would use trial antithrombotic combinations in normal clinical practice
Able to provide informed consent
First time in the CLARITY trial

Open bypass as part of hybrid procedure
Intervention for asymptomatic restenosis of a bypass graft
Pre-existing indication for dual antiplatelet therapy or anticoagulant e.g. atrial fibrillation
Active malignancy or any other non-vascular condition associated with a life expectancy of less than 36 months
Embolic arterial disease
Renal failure with creatinine clearance <15ml/minute
Thrombophilia or any other inherited or acquired bleeding disorder
People assigned female at birth and of childbearing potential who have a positive pregnancy test, are breastfeeding or attempting pregnancy

Patients can be consented either pre or post procedure.
Patients cannot be randomised until confirmed by medical team that the procedure has been successful. Trial medication must be commenced within 10 days of the procedure

Inform the patient that they may be eligible for a research study
Gain verbal agreement in principle before proceeding. Explain:
Taking part in research is likely to improve the quality of their care
Risks are carefully controlled - research is safe
Explain the uncertainty that exists with respect to treatment of their condition
If they change their mind they can withdraw their participation at any point

Step-by-Step Guide to Recruitment:

Patients can be recruited as in patients or from day case radiology.
Contact research nurse team to provide PIS to patient.
Medical staff on delegation log need to confirm eligibility twice - pre and post procedure - and document on EPIC using smartphrases .CLARITYINPATIENTELIGIBILITY and .CLARITYCONFIRMATIONELIGIBILITY.
Research Nurse Team can they complete baseline assessments and randomisation.
Local routine prescribing procedures will be followed for each IMP; for example the Investigation Medicinal Product [IMP] will be prescribed by the participant’s treating clinician according to the trial arm allocation and either dispensed by the hospital pharmacy department or a community pharmacy.

Eligibility can only be confirmed by medical team on delegation log.
Mr Graeme Amble, consultant vascular surgeon, is the PI and will know which members of staff who are delegated this role.

Clinical team to have initial conversation with the patient and ask if details can be passed to the research nurse team.
Patient video animation available at https://www.claritypadtrial.co.uk/
Tap the buttons below to show/hide a QR code link to the patient information video, or go to the site:

Research nurse team to send out PIS and follow up to see if they are interested.
Medical team member on the study delegation log to take consent on paper face to face.
Research nurses will ensure the doctor receiving consent has the correct version of the form.
Doctor to complete smartphrases on Epic; .CLARITYINPATIENTELIGIBILITY and .CLARITYCONFIRMATIONELIGIBILITY

The research nurse team is available from 08am-16pm Monday to Friday;
In research team working hours contact the team via:
- Secure Chat: Research Delivery Team
- Email: cuh.rdt@nhs.net

Research Nurse team will complete randomisation and inform clinical teams so allocated drugs can be prescribed.

Any Dr from the clinical or research teams can complete the prescriptions.
NICE recommends the co-prescription of a proton pump inhibitor for patients at high risk of gastrointestinal bleeding being prescribed dual antiplatelet therapy following coronary artery endovascular intervention to reduce this risk
Omeprazole, a widely prescribed proton pump inhibitor, interacts with clopidogrel and may reduce effectiveness.
As a result, we recommend that trial patients have a proton pump inhibitor considered with any history or concern about gastrointestinal bleeding. Patients already taking omeprazole or esomeprazole should be switched to lansoprazole or pantoprazole, which are both available in generic form.

Follow up as per standard of care.
Research Nurses will see participants at routine appointments or follow up remotely.
All patients should be treated with ‘best care’ concomitant risk factor reduction medication as per NICE guidelines.
This includes high-dose statin therapy, blood pressure and diabetic control, and smoking cessation help.
Patients taking other doses of anticoagulant or antiplatelet medication are excluded by the inclusion/exclusion criteria.
Patients being admitted to the hospital during the trial should have thromboprophylaxis (usually with low molecular weight heparin) as per local protocol

Following discharge from hospital, prescriptions will continue to be provided by GP.
Research Nurses will send a letter to the GP after randomisation.