Triple therapy following implantation of everolimus drug-eluting stent in patients with prior phenprocoumon treatment

ISRCTN	ISRCTN11083141
DOI	https://doi.org/10.1186/ISRCTN11083141
Protocol serial number	DAPT-Triple
Sponsor	University Hospital Münster
Funder	University Hospital Münster

Submission date: 20/01/2017
Registration date: 24/03/2017
Last edited: 24/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Atrial fibrillation is a condition where the heart rate is irregular and often abnormally fast. This increases the risk of blood clots forming in the heart chambers, which can enter the bloodstream and cause a stroke. Patients are therefore prescribed anticoagulant medicines to prevent blood clots. These 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. This combination of medications causes a high risk of bleeding, but is necessary to prevent both strokes and stent clotting. 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 (Xience).

Who can participate?
Patients aged over 18 with coronary artery disease, treated with stent implantation at Münster University Hospital, who require anticoagulant medication due to atrial fibrillation

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?
June 2015 to December 2016

Who is funding the study?
University Hospital Münster (Germany)

Who is the main contact?
Dr Dieter Fischer

Contact information

Dr Dieter Fischer
Scientific

Albert-Schweitzer-Campus 1
Muenster
48149
Germany

ORCID ID	0000-0002-5047-7494

Study information

Primary study design	Observational
Study design	Retrospective observational study
Secondary study design	Case series
Study type	Participant information sheet
Scientific title	Triple therapy following implantation of everolimus drug-eluting stent in patients with prior phenprocoumon treatment: a retrospective observational study
Study objectives	To evaluate the safety and efficacy of a modified anticoagulation strategy in this specific patient cohort after everolimus DES Implantation and prior anticoagulation therapy.
Ethics approval(s)	Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität, 04/05/2015, ref: 2015-203-f-S
Health condition(s) or problem(s) studied	Coronary artery disease, atrial fibrillation
Intervention	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	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	1. Safety of triple therapy, measured using a standardized questionnaire at a single follow-up timepoint 2. Efficacy of triple therapy, measured using a standardized questionnaire at a single follow-up timepoint
Key secondary outcome measure(s)	Risk factors for events (bleeding or thrombotic), measured using a standardized questionnaire at a single follow-up timepoint
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Patients with coronary artery disease 2. Treated with drug-eluting stent implantation at Münster University Hospital 3. Indication for oral anticoagulation due to atrial fibrillation 4. Age > 18 years
Key exclusion criteria	1. Age < 18 years 2. Current pregnancy 3. Underlying malignant disease 4. Previous stent thrombosis 5. Active bleeding 6. Other OAC indications than atrial fibrillation (e.g. pulmonary embolism, mechanical valves) 7. Patients who were unable to give informed consent
Date of first enrolment	01/06/2015
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Münster

Department of Cardiovascular Medicine
Münster
48149
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Dieter Fischer.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes