Peripheral Vascular Disease (Critical Limb Ischaemia)
Conditions
Interventions
Trade Name: Plavix
Product Name: Plavix
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Lothian NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 40-80 years scheduled for infra-inguinal lower limb revascularisation or amputation for critical limb ischaemia will be recruited into the trial. Critical limb ischemia will be defined as breakdown of the skin (ulcer or gangrene) and/or pain in the foot even at rest as a result of arterial disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Non-atherosclerotic vascular disease Sudden acute limb ischaemia requiring emergency surgery within a few hours Patients scheduled for supra-inguinal or aortic surgery Acute coronary syndrome within 3 months before surgery Current active bleeding (e.g. peptic ulcer disease) Previous or current intracranial haemorrhage Plan for epidural or spinal anaesthesia Bleeding diathesis Uncontrolled hypertension Thrombocytopenia Pregnancy Hypersensitivity or allergy to thienopyridines Current warfarin or thienopyridine use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The comparison of levels of Platelet-Monocyte binding in different patient groups;Main Objective: To assess the effect of pre-operative clopidogrel therapy, on markers of platelet activation (platelet-monocyte binding), in patients undergoing surgery for critical limb ischaemia.; Secondary Objective: 1. To assess the effect of additional pre-operative clopidogrel therapy, on CD40/CD40L levels in patients undergoing surgery for critical limb ischaemia. 2. To compare levels of platelet-monocyte binding and CD40/CD40L, in patients having surgery for critical limb ischaemia with control subjects. 3. To compare levels of Troponin I generated by different patient groups. 4. To assess any differences in incidence of bleeding complications and acute coronary syndromes, between the clopidogrel and placebo groups. | — |
Countries
United Kingdom
Outcome results
None listed