Short antithrombotic therapy after stent implantation in high bleeding risk patients
| ISRCTN | ISRCTN65588717 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65588717 |
| Secondary identifying numbers | DAPT_DF |
- Submission date
- 28/11/2018
- Registration date
- 18/12/2018
- Last edited
- 27/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Patients are often implanted with a short wire-mesh tube, called a stent, into their coronary (heart) arteries. After that, they need an antithrombotic medication that reduces the formation of blood clots in order to keep the stent open. Many patients are at high risk of bleeding, but is necessary to prevent stent clotting, which is difficult in daily practice. Therefore, modern stents are implanted that allow a very short time period of this combined medication. The best time period for this combination is unclear. The aim of this study is to assess the risks and the benefits of a short period of combination treatment in patients after implantation of a specific coronary stent (Biofreedom) in high bleeding risk patients.
Who can participate?
Patients aged over 18 with coronary artery disease, treated with stent implantation at Münster University Hospital, who are at high risk for bleeding
What does the study involve?
All participants are contacted once in the follow-up period. Adverse events (side effects) due to both bleeding and thromboembolic (blood clotting) reasons are recorded, including death, myocardial infarction (heart attack), stent clotting, stroke, and major bleeding. The participants’ intake of medication is also recorded.
What are the possible benefits and risks of participating?
The results may help determine the best duration of treatment in the future. There are no risks for the participants because the treatment is standard of care according to guidelines.
Where is the study run from?
University Hospital Münster (Germany)
When is the study starting and how long is it expected to run for?
July 2015 to February 2019
Who is funding the study?
University Hospital Münster (Germany)
Who is the main contact?
Dr Dieter Fischer
dieterfischer@yahoo.de
Contact information
Public
Albert-Schweitzer-Campus 1, Geb. A1
Muenster
48143
Germany
| Phone | +49 (0)1737175707 |
|---|---|
| dieterfischer@yahoo.de |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Implantation Of Biofreedom® drug-coated stents with very short dual antiplatelet therapy In patients at high bleeding risk: real-world data |
| Study acronym | Biofreedom short DAPT |
| Study objectives | Patients at high risk of bleeding requiring percutaneous coronary intervention (PCI) are a challenging group who need careful evaluation of both their thrombotic and bleeding risks. Deciding on duration and intensity of antithrombotic management is difficult and has to be well balanced. In these patients, a polymer-free metallic stent coated with biolimus-A9 (Biofreedom®) followed by a one-month dual antiplatelet therapy has shown to be safer and more effective when compared to a bare metal stent during a two year follow-up (LEADERS-free trial). Yet, data on safety and efficacy outside a trial are scare. Therefore, the trialists analyzed this regimen in a real-world scenario. |
| Ethics approval(s) | Ethics committee of the University of Muenster (Germany) and the Aerztekammer Westfalen-Lippe (Muenster, Germany), 05/10/2016, ref: 2016-487-f-S |
| Health condition(s) or problem(s) studied | Patients with coronary artery disease and indication for PCI |
| Intervention | Short antiplatelet therapy after implantation of the Biofreedom DE-stent in a real world scenario All patients will be contacted once in the follow-up period. Adverse events for both bleeding and thromboembolic reasons will be analysed (death, myocardial infarction, stent thrombosis, stroke, major bleeding). Furthermore, the intake of medication (duration) will be recorded. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Safety of a short antithrombotic therapy after stent implantation, measured using a standardized questionnaire at a single follow-up timepoint 2. Efficacy of short antithrombotic therapy, measured using a standardized questionnaire at a single follow-up timepoint |
| Secondary outcome measures | Risk factors for events (bleeding or thrombotic), measured using a standardized questionnaire at a single follow-up timepoint |
| Overall study start date | 01/07/2015 |
| Completion date | 01/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 89 |
| Key inclusion criteria | 1. Implantation of at least one Biofreedom® stent for the treatment of significant CAD during the study period 2. At least one criterion for high risk bleeding |
| Key exclusion criteria | 1. Aged <18 years 2. Current pregnancy 3. Underlying malignant disease 4. Active bleeding 5. Unable to give informed consent |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 01/11/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
Münster
48143
Germany
Sponsor information
University/education
Albert-Schweitzer-Campus 1, Geb. A1
Muenster
48143
Germany
"ROR" |
https://ror.org/01856cw59 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Abstract at the CRT Congress in Washington DC 2017 2. Publication in a cardiology journal in English |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Dieter Fischer (dieterfischer@yahoo.de). Data will be stored in the study department (computer and paper, e.g. informed consents). Access to data is possible 24/7 for authorized personnel and also for official inspections. Study data will be stored at least for 15 years. All data is anonymized, the written informed consents are also stored in the study department of the clinic. There are no legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/01/2020 | 27/09/2021 | Yes | No |
Editorial Notes
27/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
