Defibrillator After Primary Angioplasty randomised trial
| ISRCTN | ISRCTN42195152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42195152 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr J Klijn
Scientific
Scientific
Diagram B.V.
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
| Phone | +31 (0)38 426 2997 |
|---|---|
| j.klijn@diagram-zwolle.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Defibrillator After Primary Angioplasty randomised trial |
| Study acronym | DAPA |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 03/03/2004 |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 700 |
| Total final enrolment | 266 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/03/2004 |
| Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diagram B.V.
Zwolle
8011 NB
Netherlands
8011 NB
Netherlands
Sponsor information
Individual Sponsor (Netherlands)
Other
Other
Dr A R Ramdat Misier
Isala klinieken
lokatie 'De Weezenlanden'
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
Funders
Funder type
Industry
Medtronic B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 26/03/2021 | No | No |
Additional files
- ISRCTN42195152_BasicResults_2019.pdf
- uploaded 26/03/2021
Editorial Notes
The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. The total final enrolment was added.
