Condition category
Circulatory System
Date applied
28/11/2018
Date assigned
18/12/2018
Last edited
18/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Dieter Fischer

ORCID ID

Contact details

Albert-Schweitzer-Campus 1
Geb. A1
Muenster
48143
Germany
+49 (0)1737175707
dieterfischer@yahoo.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DAPT_DF

Study information

Scientific title

Implantation Of Biofreedom® drug-coated stents with very short dual antiplatelet therapy In patients at high bleeding risk: real-world data

Acronym

Biofreedom short DAPT

Study hypothesis

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

Ethics committee of the University of Muenster (Germany) and the Aerztekammer Westfalen-Lippe (Muenster, Germany), 05/10/2016, ref: 2016-487-f-S

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/07/2015

Overall trial end date

01/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Age < 18 years
2. Current pregnancy
3. Underlying malignant disease
4. Active bleeding
5. Unable to give informed consent

Recruitment start date

01/10/2015

Recruitment end date

01/11/2016

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital, Dept. Cardiology
Albert-Schweitzer-Campus 1, Geb. A1
Münster
48143
Germany

Sponsor information

Organisation

University Hospital of Muenster

Sponsor details

Albert-Schweitzer-Campus 1
Geb. A1
Muenster
48143
Germany

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Abstract at the CRT Congress in Washington DC 2017
2. Publication in a cardiology journal in English

IPD sharing statement
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.

Intention to publish date

01/02/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes