A clinical trial to demonstrate that an early as possible treatment of atrial fibrillation can prevent a stroke.

Phase 1

• Conditions: Atrial fibrillation, stroke, heart failure, myocardial infarction, cognitive dysfunction; MedDRA version: 18.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.1Level: HLGTClassification code 10019280Term: Heart failuresSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.1Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.1Level: HLGTClassification code 10009841Term: Cognitive and attention disorders and disturbancesSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 18.1Level: PTClassification code 10019016Term: Haemorrhagic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-021258-20-NL
• Lead Sponsor: Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-10
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2810

Inclusion Criteria

1. Recent-onset AF (= 1 year prior to enrolment)
2. At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 s.
3. EITHER
one of the following:
* age > 75 years or
* prior stroke or transient ischemic attack
OR
two of the following:
* age > 65 years,
* female sex,
* arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg),
* diabetes mellitus (treated by drugs or insulin) or impaired glucose tolerance
* severe coronary artery disease (previous myocardial infarction, CABG or PCI)
* stable heart failure ( NYHA II or LVEF <50%),
* left ventricular hypertrophy on echocardiography (more than 15 mm wall thickness),
* chronic kidney disease (MDRD stage III or IV),
* peripheral artery disease.

4. Provision of signed informed consent.
5. Age = 18 years.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 810
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

1. Any disease that limits life expectancy to less than 1 year.
2. Participation in another clinical trial, either within the past two months or ongoing
3. Previous participation in the EAST trial.
4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized.
5. Breastfeeding women.
6. Drug abuse.
7. Prior AF ablation or surgical therapy of AF.
8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone.
9. Patients not suitable for rhythm control of AF.
10. Severe mitral valve stenosis.
11. Prosthetic mitral valve.
12. Clinically relevant hepatic dysfunction requiring specific therapy.
13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified