Condition category
Circulatory System
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
14/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.diagram-zwolle.nl

Contact information

Type

Scientific

Primary contact

Mr J Klijn

ORCID ID

Contact details

Diagram B.V.
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
+31 (0)38 426 2997
j.klijn@diagram-zwolle.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DAPA

Study hypothesis

Sudden cardiac death is a major cause of death after Acute Myocardial Infarction (AMI). Several studies have shown that an Implantable Cardioverter Defibrillator (ICD) is superior to anti-arrhythmic drug treatment in patients who survived an arrhythmic cardiac arrest or an episode of life-threatening ventricular tachycardia. Furthermore, ICD as primary prevention therapy has been accepted in patients with coronary artery disease, decreased systolic Left Ventricular (LV) function and inducible sustained ventricular tachyarrhythmias. Recently, a prospective randomised study showed that defibrillator therapy was beneficial when added to optimal drug treatment in patients with reduced LV function who survived a myocardial infarction (MI). However, it is not known which patients who have mechanical reperfusion as therapy for AMI could have benefit of prophylactic ICD therapy to reduce sudden cardiac death. Furthermore, since LV function improves in the months after MI, particularly after primary Percutaneous Coronary Intervention (PCI), prophylactic ICD implantation based solely on LV function in the post acute phase of MI is probably not a good criterium for ICD implantation within 30 days.

The aim of the study is to demonstrate a survival benefit of ICD in patients with high-risk characteristics after primary angioplasty for acute MI.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular

Intervention

Patients will be randomised in a 1:1 ratio to receive either ICD implantation with conventional medical therapy versus conventional medical therapy alone. All patients will be treated with optimised drug-therapy including angiotensin-converting enzyme inhibitors, alpha-blockers, aspirin and lipid-lowering drugs where appropriate. Additional revascularisation procedures are to the discretion of the investigators.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary endpoint of the study is all-cause mortality.

Secondary outcome measures

Secondary endpoints are the incidence of sudden cardiac death and sustained Ventricular Tachycardia (VT). Sudden cardiac death is defined as occurring within one hour of the onset of symptoms or, if death is not witnessed, during sleep or within 24 hours of last occasion on which the patient was seen in a healthy state.

Overall trial start date

03/03/2004

Overall trial end date

31/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. ST-elevation myocardial infarction treated with primary PCI within 30 days and 60 days before randomisation
2. At least one of the following criteria:
a. Thrombolysis In Myocardial Infarction (TIMI) flow after primary PCI less than three in the infarct related vessel
b. Left ventricular ejection lower than 30% as measured within four days after admission

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

700

Participant exclusion criteria

1. Class I indication for ICD implantation
2. Documented previous myocardial infarction with Left Ventricular Ejection Fraction (LVEF) less than 30%
3. Age less than 18 years
4. Heart failure with New York Heart Association functional class IV
5. Inotropic medication within two weeks before randomisation
6. Mechanical tricuspid valve
7. Serious comorbidity such as cancer, with a high likelihood of death during the trial
8. Advanced cerebrovascular disease
9. Unwilling or unable to sign the consent form for participation
10. Females of childbearing age not using medically prescribed contraceptives

Recruitment start date

03/03/2004

Recruitment end date

31/03/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Diagram B.V.
Zwolle
8011 NB
Netherlands

Sponsor information

Organisation

Individual Sponsor (Netherlands)

Sponsor details

Dr A R Ramdat Misier
Isala klinieken
lokatie 'De Weezenlanden'
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands

Sponsor type

Other

Website

Funders

Funder type

Industry

Funder name

Medtronic B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes