Antithrombotic treatment after percutaneous or hybrid endovascular intervention for chronic limb-threatening ischemia of the lower limbs Circulatory System
Conditions
Interventions
Oral course (up to 36 months) of one of the following treatments:
1. A 75mg clopidogrel tablet taken once daily
2. Dual antiplatelet therapy with a 75mg aspirin tablet and 75mg clopidogrel tablet, bot
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (aged 18 years and over) undergoing percutaneous or hybrid endovascular intervention for CLTI of the lower limbs 2. Atherosclerosis as the cause of CLTI 3. Target arteries: infrainguinal (common femoral to pedal) if percutaneous, or iliac to pedal if performed as part of hybrid revascularisation with common femoral endarterectomy 4. Clinicians would use trial antithrombotic combinations in normal clinical practice 5. Able to provide informed consent 6. First time in the CLARITY trial
Exclusion criteria
Exclusion criteria: 1. Open lower-limb bypass as part of hybrid procedure 2. Pre-existing clinical indication for dual antiplatelet therapy or anticoagulant e.g. atrial fibrillation 3. Active malignancy or any other non-vascular condition associated with a life expectancy of less than 36 months 4. Patients undergoing intervention to treat asymptomatic restenosis of a lower-limb bypass graft 5. Embolic arterial disease 6. Renal failure with creatinine clearance <15ml/minute 7. Thrombophilia or any other inherited or acquired bleeding disorders 8. Persons of childbearing potential who have a positive pregnancy test, are breastfeeding or attempting pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite event-free survival time of: 1.Acute limb ischaemia 2.Major lower limb amputation 3.Myocardial infarction 4.Ischaemic stroke 5.All-cause mortality Measured using patient records at 2 months, 6 months, 12 months, 24 months and 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured via case report forms (CRFs) or questionnaires either from patient notes or directly from participants at 2 months, 6 months, 12 months, 24 months and 36 months: 1. Major adverse limb events (MALE) (defined as amputation or major reintervention of the trial limb) 2. Major adverse cardiovascular events (MACE) (defined as recurrent CLTI, amputation affecting contralateral limb, acute coronary syndrome, ischaemic stroke) 3. Bleeding Academic Research Consortium (BARC 2, 3 or 5) and Thrombolysis In Myocardial Infarction (TIMI) defined major bleeding 4. Minor bleeding 5. Primary and secondary patency of artery 6. Reintervention 7. Healing of tissue loss 8. Health-related quality of life (VascuQoL and EQ-5D-5L) 9. Cost-effectiveness 10. Qualitative process evaluation | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed