Effect of dronedarone on Cardiac patients with permenant atrial fibrilation (i.e.irregular heart beat)

Phase 3

• Conditions: Health Condition 1: null- Permanent Atrial fibriLLAtionHealth Condition 2: I489- Unspecified atrial fibrillation and atrial flutter

• Registration Number: CTRI/2011/06/001844
• Lead Sponsor: SanofiSynthelabo India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 10800

Inclusion Criteria

1. Patients in permanent atrial fibrillation with additional risk

factors

2. Patients in permanent atrial fibrillation defined by the

presence of all of the following criteria:

1. Availability of one 12-lead ECG not more than 14

days prior to randomization, showing that the patient

is in atrial fibrillation or atrial flutter

2. Availability of documentation (including either rhythm

strips or medical report of the rhythm) showing that

the patient was in atrial fibrillation or atrial flutter at

least 6 months prior to randomization

3. No evidence of sinus rhythm in the period between

these two documentations of atrial fibrillation

4. Patient and physician decision to allow atrial

fibrillation to continue without further efforts to restore

sinus rhythm

5.Patients aged 65 years or older with at least one of the

following risk factors or combination of risk factors:

1.Coronary artery disease

2. Prior stroke or TIA

3. Symptomatic heart failure

4. Left ventricular ejection fraction less than or equal to

0.40

5. Peripheral arterial occlusive disease

6. Aged 75 years or older with both hypertension and

diabetes mellitus

Exclusion Criteria

Exclusion Criteria (selection)

E 01. Patients in paroxysmal atrial fibrillation

E 02. Patients in persistent atrial fibrillation without a decision to

allow atrial fibrillation to continue without further efforts to

restore sinus rhythm

E 11. Patients with heart failure of NYHA class IV or recent

unstable NYHA class III

Study & Design

• Study Type: Interventional
• Study Design: Not specified