Triple therapy following implantation of everolimus drug-eluting stent in patients with prior phenprocoumon treatment
| ISRCTN | ISRCTN11083141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11083141 |
| Secondary identifying numbers | DAPT-Triple |
- 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
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
Scientific
Albert-Schweitzer-Campus 1
Muenster
48149
Germany
 ORCID ID |
0000-0002-5047-7494 |
|---|
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/06/2015 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Münster
48149
Germany
Sponsor information
Hospital/treatment centre
Department of Cardiovascular Medicine
Albert-Schweitzer-Campus 1
Münster
D-48149
Germany
"ROR" |
https://ror.org/01856cw59 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/07/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
