Condition category
Circulatory System
Date applied
16/06/2008
Date assigned
23/06/2008
Last edited
16/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Newby

ORCID ID

Contact details

The Chancellors Building
The New Royal Infirmary of Edinburgh
49 Little France Crescent
Edinburgh
EH16 4SU
United Kingdom

Additional identifiers

EudraCT number

2005-000960-25

ClinicalTrials.gov number

Protocol/serial number

2005/R/CAR/04

Study information

Scientific title

The role of platelet activation and inflammation in the adverse Cardiovascular outcomes of patients undergoing surgery for Critical Limb ISchaemia: a double-blind randomised controlled trial of clopidogrel

Acronym

CCLIS

Study hypothesis

We hypothesised that in patients undergoing surgical intervention for critical limb ischaemia:
1. Platelet activation would be increased in patients who subsequently develop a post-operative acute coronary syndrome
2. Additional clopidogrel therapy would reduce markers of systemic inflammation and platelet activation

Ethics approval

Ethics approval received from the Fife and Forth Valley Local resaerch Ethics Committee on the 4th April 2005 (ref: 05/S0501/41; Eudract Number: 2005-000960-25).

Study design

Interventional single-centre, prospective double-blind randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Critical limb ischaemia

Intervention

Pre-operative dual anti-platelet therapy versus single anti-platelet therapy. Patients were maintained on aspirin (75 mg/day) and were randomised to clopidogrel (600 mg prior to surgery, and 75 mg daily for three days) or matched placebo.

Total duration of treatment = 4 days (pre-operative loading dose of 600 mg clopidogrel/placebo, plus 75mg/day for 3 days starting on the morning of surgery).
Total duration of follow up = 6 months following surgery.

Intervention type

Drug

Phase

Not Specified

Drug names

Clopidogrel

Primary outcome measures

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

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
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
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

Overall trial start date

01/09/2005

Overall trial end date

29/02/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

29/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Chancellors Building
Edinburgh
EH16 4SU
United Kingdom

Sponsor information

Organisation

Lothian Health Board (LHB) (UK)

Sponsor details

c/o Heather Cubie
49 Little France Crescent
Edinburgh
EH16 4SU
United Kingdom

Sponsor type

Government

Website

http://www.research.luht.scot.nhs.uk/home.htm

Funders

Funder type

Research organisation

Funder name

British Heart Foundation (UK) (ref: FS/05/038)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

European Society of Vascular Surgery (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal College of Surgeons of Edinburgh (UK)

Alternative name(s)

RCSEd

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

Sanofi Aventis (UK) - unrestricted Educational Award

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20562608

Publication citations

  1. Results

    Burdess A, Nimmo AF, Garden OJ, Murie JA, Dawson AR, Fox KA, Newby DE, Randomized controlled trial of dual antiplatelet therapy in patients undergoing surgery for critical limb ischemia., Ann. Surg., 2010, 252, 1, 37-42, doi: 10.1097/SLA.0b013e3181e40dde.

Additional files

Editorial Notes