The role of platelet activation and inflammation in the associated cardiac complications of surgery for peripheral arterial disease: the benefits of additional clopidogrel therapy

Completed

Conditions: Critical limb ischaemia
Circulatory System
Arterial embolism and thrombosis

Registration Number: ISRCTN22305120

Lead Sponsor: othian Health Board (LHB) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Patients aged greater than 45 years, either sex
2. Critical limb ischaemia, defined as the presence of rest pain or skin breakdown, and an ankle-brachial pressure index less than 0.2
3. Scheduled for infra-inguinal bypass, endarterectomy or amputation under general anaesthesia

Exclusion Criteria

1. Women of child bearing potential
2. Non-atherosclerotic vascular disease
3. Sudden acute limb ischaemia requiring emergency surgery
4. Supra-inguinal or aortic surgery
5. History of acute coronary syndrome within three months
6. History of peptic ulcer disease
7. Previous or current intracranial haemorrhage
8. Bleeding diathesis
9. Uncontrolled hypertension or thrombocytopenia
10. Planned epidural or spinal anaesthesia
11. Hypersensitivity or allergy to thienopyridines
12. Current warfarin or thienopyridine use

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Markers of in vivo platelet activation (platelet-monocyte aggregates and platelet expression of P-selectin), measured before study drug, after study drug, post-operatively in the recovery room and between 8 am - 10 am on day one following surgery.

Secondary Outcome Measures

Name	Time	Method
1. Markers of myocardial injury (cardiac troponin I [cTn-I]), measured before study drug, after study drug, post-operatively in the recovery room and between 8 am - 10 am on day one following surgery<br>2. Bleeding outcomes (thrombosis in myocardial infarction [TIMI] and clopidogrel in unstable angina to prevent recurrent events [CURE] classifications); any bleeding events occuring from the time of surgery to hospital discharge<br>3. Cardiovascular events (acute coronary syndrome, transient ischaemic attack, stroke, death from cardiovascular cause) recorded from time of surgery to hospital discharge, within three months of surgery and within six months of surgery