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Can the use of statin reduce the incidence of atrial flutter after major non-cardiac thoracic surgery ? A randomised double-blind study.

Can the use of statin reduce the incidence of atrial flutter after major non-cardiac thoracic surgery ? A randomised double-blind study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001124-31-BE
Enrollment
Unknown
Registered
2008-03-17
Start date
2008-04-11
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Prevention of atrial flutter after major non-cardiac thoracic surgery.

Interventions

Trade Name: Prareduct Pharmaceutical Form: Capsule, hard INN or Proposed INN: pravastatine CAS Number: 81093-37 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-

Sponsors

UZ Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - intake of steroids - intake of NSAID's - intake of immunosuppressants - known severe renal insufficiency - known liver disease

Design outcomes

Primary

MeasureTime frame
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.

Countries

Belgium

Outcome results

None listed

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