Role of Inflammation and Platelet Activation in the adverse Cardiovascular Outcomes of Patients with Critical Limb Ischaemia - a double-blind randomised trial of Clopidogrel. - Platelet activation and Clopidogrel in Critical Limb Ischaemia

Phase 1

• Conditions: Peripheral Vascular Disease (Critical Limb Ischaemia)

• Registration Number: EUCTR2005-000960-25-GB
• Lead Sponsor: othian NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-05
• Study Completion: 2009-07-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;<br> 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.<br> 2. To compare levels of platelet-monocyte binding and CD40/CD40L, in patients having surgery for critical limb ischaemia with control subjects.<br> 3. To compare levels of Troponin I generated by different patient groups.<br> 4. To assess any differences in incidence of bleeding complications and acute coronary syndromes, between the clopidogrel and placebo groups.<br>