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Amiodarone prophylaxis for atrial fibrillation in patients undergoing surgery for lung cancer: A controlled, randomized, double blinded trial. - PASCART

Amiodarone prophylaxis for atrial fibrillation in patients undergoing surgery for lung cancer: A controlled, randomized, double blinded trial. - PASCART

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005246-20-DK
Enrollment
275
Registered
2008-02-15
Start date
2008-03-11
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Atrial fibrillation after lung resection due to cancer in the lung MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation MedDRA version: 9.1 Level: LLT Classification code 10025065 Term: Lung carcinoma cell type unspecified recurrent

Interventions

Trade Name: Cordarone Pharmaceutical Form: Tablet INN or Proposed INN: Amiodarone CAS Number: 19774824 Other descriptive name: Cordarone Concentration unit: mg milligram(s) Concentration type: equal C

Sponsors

Aarhus University Hospital, Skejby
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Enlisted for lungresection due to pulmonary neoplasma 2) Elective surgery 3) Willingness of randomisation 4) Above 18 years 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) Former pulmonary surgery performed 2) Former heart surgery 3) Resting heart beat below 40 beats/ min 4) AV-blockage of any degree 5) Paroxysmal, persistent or permanent atrial fibrillation or flutter 6) Former insidence of paroxysmal, persistent or permanent atrial fibrillation or flutter 7) Pregnant 8) Breastfeeding 9) Allergy towards the substances in cordarone

Design outcomes

Primary

MeasureTime frame
Main Objective: To reduce the incidence of atrial fibrillation after lung resection due to lung cancer;Secondary Objective: To compile the cost-effectiveness of the instituted prophylaxis;Primary end point(s): 1) Atrial fibrillation 2) Symptomatic atrial fibrillation 3) Length of stay

Countries

Denmark

Outcome results

None listed

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