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| [ Print-friendly version ] |
| The role of platelet activation and inflammation in the associated cardiac complications of surgery for peripheral arterial disease: the benefits of additional clopidogrel therapy |
| ISRCTN | ISRCTN22305120 |
| ClinicalTrials.gov identifier | |
| Public title | The role of platelet activation and inflammation in the associated cardiac complications of surgery for peripheral arterial disease: the benefits of additional clopidogrel therapy |
| 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 |
| Serial number at source | 2005/R/CAR/04 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Critical limb ischaemia |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2005 |
| Anticipated end date | 29/02/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 100 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding |
1. British Heart Foundation (UK) (ref: FS/05/038)
2. European Society of Vascular Surgery (Denmark) 3. Royal College of Surgeons of Edinburgh (UK) 4. Sanofi Aventis (UK) - unrestricted Educational Award |
| Trial website | |
| Publications | |
| Contact name | Prof David Newby |
| Address |
The Chancellors Building
The New Royal Infirmary of Edinburgh 49 Little France Crescent |
| City/town | Edinburgh |
| Zip/Postcode | EH16 4SU |
| Country | United Kingdom |
| Sponsor | Lothian Health Board (LHB) (UK) |
| Address |
c/o Heather Cubie
49 Little France Crescent |
| City/town | Edinburgh |
| Zip/Postcode | EH16 4SU |
| Country | United Kingdom |
| Sponsor website: | http://www.research.luht.scot.nhs.uk/home.htm |
| Date applied | 16/06/2008 |
| Last edited | 23/06/2008 |
| Date ISRCTN assigned | 23/06/2008 |
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