Clopidogrel, aspirin and rivaroxaban after a medical procedure used to widen narrowed or blocked arteries using a balloon or stent (CLARITY)

Phase 4

• Conditions: Antithrombotic treatment after percutaneous or hybrid endovascular intervention for chronic limb-threatening ischemia of the lower limbs; Circulatory System

• Registration Number: ISRCTN30648419
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-22
• Last Update Posted: 2 September 2024
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1239

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite event-free survival time of: 1.Acute limb ischaemia2.Major lower limb amputation3.Myocardial infarction4.Ischaemic stroke5.All-cause mortalityMeasured using patient records at 2 months, 6 months, 12 months, 24 months and 36 months

Secondary Outcome Measures

Name	Time	Method
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 bleeding4.Minor bleeding5.Primary and secondary patency of artery6.Reintervention7.Healing of tissue loss8.Health-related quality of life (VascuQoL and EQ-5D-5L)9.Cost-effectiveness10.Qualitative process evaluation