Skip to content

A randomised placebo controlled trial of pre-operative statin use in elective abdominal aortic aneurysm repair to determine the effect on systemic and cellular responses of ischaemia reperfusion injury. - Randomised statin use for IR injury in elective AAA repair

A randomised placebo controlled trial of pre-operative statin use in elective abdominal aortic aneurysm repair to determine the effect on systemic and cellular responses of ischaemia reperfusion injury. - Randomised statin use for IR injury in elective AAA repair

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004983-56-GB
Enrollment
40
Registered
2005-02-15
Start date
2005-02-28
Completion date
Unknown
Last updated
2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemia reperfusion injury following elective abdominal aortic aneurysm repair. This occurs when muscle or organ is subjected to an ischaemic insult with associated damage followed by reperfusion with the production of oxygen free radicals which further damage local and also distant tissues. This condition occurs in many conditions including myocardial infarction, peripheral vascular disease, and various medical procedures including repair of abdominal aortic aneurysm.

Interventions

Trade Name: Lipitor 80mg Product Name: Atorvastatin 80mg Product Code: 756111000001109 Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Capsule* Route of administration of the pl

Sponsors

Hull and East Yorkshire Hospitals NHS Trust
Lead Sponsor
University of Hull
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients scheduled for elective abdominal aortic aneurysm repair. 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: 1/ Patients already on statins (3-hydroxy-3-methylglutaryl coenzyme A {HMG CoA} reductase inhibitors). 2/ Patients with unilateral or bilateral lower limb amputations. 3/ Participation in other trials with investigational treatment for ischaemia reperfusion injury. 4/ Inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: Investigating systemic and cellular responses to ischaemia reperfusion injury after pre-operative statin use for a month in comparison to double blinded placebo users.;Secondary Objective: ;Primary end point(s): Blood and urine sampling 24 hours after completion of aneurysm repair.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026