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

• Register: EUCTR
• Last refreshed on: 16 November 2020
• Main ID: EUCTR2010-021258-20-NL
• Date of registration: 10/08/2011
• Prospective Registration: Yes
• Primary sponsor: Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.)
• Public title: A clinical trial to demonstrate that an early as possible treatment of atrial fibrillation can prevent a stroke.
• Scientific title: Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST) - EAST
• Date of first enrolment: 26/10/2011
• Target sample size: 2810
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021258-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: usual care as defined by the current ESC guidelines and including delayed rhythm control therapy Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Contacts

• Name: Clinical Trials Information
• Affiliation: Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.)

• Name: Clinical Trials Information
• Affiliation: Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.)

Key inclusion & exclusion criteria

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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Atrial fibrillation, stroke, heart failure, myocardial infarction, cognitive dysfunction
MedDRA version: 18.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 18.1 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 18.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 18.1 Level: HLGT Classification code 10009841 Term: Cognitive and attention disorders and disturbances System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 18.1 Level: PT Classification code 10019016 Term: Haemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Pharmaceutical Form:

Primary Outcome(s)

Main Objective: To test whether an early and comprehensive rhythm control therapy can prevent adverse cardiovascular outcomes in patients with atrial fibrillation (AF) compared to usual care.

Primary end point(s): A composite of cardiovascular death, stroke, transitoric ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome.
The first co-primary outcome parameter is defined as the time to the first occurrence of a composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary.
The second co-primary outcome parameter is nights spent in hospital per year.

Secondary Objective: n.a.

Timepoint(s) of evaluation of this end point: A first interim analysis is to be performed when the first 171 events in the 1st co-primary outcome have been observed. If the assumptions are met, this will happen 32 months after the first patient was randomized.
The second interim analysis is to be performed when the first 343 events in the 1st co-primary outcome have been observed (approximately 47 months after the first patient was randomized).
The third interim analysis is to be performed when the first 514 events have been observed (approximately 59 (11) months after the first (last) patient was randomized).
The final analysis is to be performed when 685 events have been observed. If the assumptions are met, this will happen 72 (24) months after the first (last) patient was randomized.

Secondary Outcome(s)

Secondary end point(s): 1. Cardiovascular death
2. stroke
3. worsening of heart failure assessed by hospitalizations
4. acute coronary syndrome assessed by hospitalizations
5. time to recurrent atrial fibrillation
6. cardiovascular hospitalisations
7. all-cause hospitalisations
8. left ventricular function assessed by transthoracic echocardiography
9. quality of life changes assessed by EQ-5D and SF-12
10. cognitive function assessed by MoCA

Timepoint(s) of evaluation of this end point: Evaluation of secondary end points no. 1-7 at the end of the trial (i.e. after 6 years).
Evaluation of secondary end points no. 8-10 at month 24 after randomisation.

Secondary ID(s)

NCT01288352

2010-021258-20-DE

ISRCTN04708680

n.a.

Source(s) of Monetary Support

Kompetenznetz Vorhofflimmern e.V. (AFNET)

Ethics review

Status: Approved
Approval date: 26/10/2011
Contact: