Condition category
Circulatory System
Date applied
20/01/2017
Date assigned
24/03/2017
Last edited
24/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dieter Fischer

ORCID ID

http://orcid.org/0000-0002-5047-7494

Contact details

Albert-Schweitzer-Campus 1
Muenster
48149
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DAPT-Triple

Study information

Scientific title

Triple therapy following implantation of everolimus drug-eluting stent in patients with prior phenprocoumon treatment: a retrospective observational study

Acronym

Study hypothesis

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

Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität, 04/05/2015, ref: 2015-203-f-S

Study design

Retrospective observational study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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 names

Primary outcome measures

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

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

01/06/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant 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

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. 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

Recruitment start date

01/06/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Münster
Department of Cardiovascular Medicine
Münster
48149
Germany

Sponsor information

Organisation

University Hospital Münster

Sponsor details

Department of Cardiovascular Medicine
Albert-Schweitzer-Campus 1
Münster
D-48149
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Münster

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results are ready to publish in 2017.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Dieter Fischer.

Intention to publish date

30/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes