Can the use of statin reduce the incidence of atrial flutter after major non-cardiac thoracic surgery ? A randomised double-blind study.
- Conditions
- Prevention of atrial flutter after major non-cardiac thoracic surgery.
- Registration Number
- EUCTR2008-001124-31-BE
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- male or female patients > 60 years
- no history of atrial flutter
- no intake of statin
- elective, major thoracic surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- intake of steroids
- intake of NSAID's
- intake of immunosuppressants
- known severe renal insufficiency
- known liver disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does the administration of 20 mg pravastatine od (starting the day before surgery) reduce the incidence of postoperative atrial flutter after major non-cardiac thoracic surgery in high risk patients ( > 60 years of age) ?;Secondary Objective: ;Primary end point(s): The primary efficacy end point of this study is the composite of total atrial flutter during the treatment period.
- Secondary Outcome Measures
Name Time Method