Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Antithrombotic drugs reduce the formation of blood clots. Many patients receive antithrombotic treatment because of an irregular heartbeat or recurrent blood clots. Traditional antithrombotic treatments (e.g. with coumarins or aspirin) may lead to severe or even lethal adverse events such as bleeding. The aim of this study is to investigate whether a best practice model that includes patient education and regular monitoring by a healthcare assistant can help to improve antithrombotic management in general practices by reducing the number of severe events.

Who can participate?
Adult patients who are expected to take antithrombotic tablets for the rest of their lives and who regularly visit their general practitioner.

What does the study involve?
Participating family practices are randomly assigned to either the intervention group or the standard care group. Patients in the intervention group receive a more intensive treatment program involving general practitioners, health care assistants and education. The healthcare assistants in particular regularly monitor patients by means of a structured checklist whenever they visit the practice. This is so the practice team can figure out certain problems with medication interaction immediately and can help to solve the problems at once. The standard care group continue to receive standard healthcare based on the provided guidelines.

What are the possible benefits and risks of participating?
We expect intensified antithrombotic care in the intervention group to lead to improved outcomes. As the study is not concerned with drug effectivness and the patients continue their assigned treatment, we do not expect participation to entail any additional risks.

Where is the study run from?
The study will be run by the Institute of General Practice and involve 46 practices in Germany.

When is the study starting and how long is it expected to run for?
May 2012 to April 2015.

Who is funding the study?
German Federal Ministry of Education and Research.

Who is the main contact?
Prof. Siebenhofer-Kroitzsch

Trial website

Contact information



Primary contact

Prof Andrea Siebenhofer-Kroitzsch


Contact details

Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
+49 (0)69 6301 7296

Additional identifiers

EudraCT number number

Protocol/serial number

(BMBF) 01GY1145

Study information

Scientific title

PrImary Care management for optimized ANtithrombotic Treatment: a cluster-randomized controlled trial



Study hypothesis

We expect that a best practice model that applies major elements of case management, including patient education, can improve antithrombotic management in primary health care in terms of reducing major thromboembolic and bleeding events in the intervention versus the standard care group.

Ethics approval

Department of Medicine, J.W. Goethe University Hospital, Frankfurt [Fachbereich Medizin, Klinikum der J.W. Goethe Universität Frankfurt], 14/11/2011, ref: E 191/11

Study design

Single-center cluster randomized controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Patients with long-term indication for antithrombotic treatment


The trial interventions will be a multifaceted intervention involving general practitioners (GPs), health care assistants (HCA) and patients. To assess adherence to medication and symptoms in patients, as well as detect complications early, HCAs will be trained in case management and will regularly monitor patients by means of the Coagulation-Monitoring-List (Co-MoL). Practice routines will be improved. For patients the intervention will include patient information, treatment monitoring via the Co-MoL and motivation to perform self-management.

The control will consist of standard primary health care based on the provided guidelines without any case-management intervention and specific patient education.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications

Secondary outcome measures

1. Mortality
2. Frequency and duration of hospitalization
3. Number of recurrent strokes, major bleeding and thromboembolic complications
4. Treatment-related quality of life analysis (EQ 5 D;The EuroQol Group. Health Policy 1990 Dec;16(3):199-208)
5. Number of treatment interactions
6. Number of adverse events
7. Quality of anticoagulation control (Siebenhofer A, Rakovac I, Kleespies C, Piso B, Didjurgeit U.
8. Self-management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial. Thromb Haemost 2008; 100(6):1089-1098)
9. Cost effectiveness evaluations (Drummond et al Methods for the Economic Evaluation of Health care Programmes. 3rd edition, Oxford University Press 2005)
10. Qualitative study analysis to describe the experience of study participants (patients, HCA, GPs) on the basis of semi-structured interviews

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Trial sites (General practices):
1. Working as a general practitioner inclusive specialists in internal medicine
2. Doctor’s agreement that health care assistants (HCAs) from the practice are allowed to participate in a structured educational course and perform specific case management duties afterwards
3. Practice provides health services to persons with German statutory health insurance
4. Practice software with the facility to detect eligible patients requiring antithrombotic treatment
5. Investigating physician agrees to the contractual obligations of the trial

1. All patients (age ≥18 years)
2. Long term indication for oral anticoagulation: atrial fibrillation, recurrent venous thromboembolism, pulmonary embolism, mechanical heart prosthesis and others such as; hereditary coagulopathy, intracardial thrombosis
3. Given indication for coumarins, antiplatelet therapies or the new antithrombotic agents rivaroxaban and dabigatran
4. Patient is capable to give a free and written informed consent to participate in the trial, to fill in questionnaires and to participate in telephone interviews.
5. Care is provided by a general practitioner (GP) working at a trial site (at least one contact in the last 12 months)
6. Patient is legally competent to sign any documents

Participant type


Age group




Target number of participants

345 per group, 690 in total

Participant exclusion criteria

1. Lack of German language skills
2. Diseases causing life expectancy of < 6 months
3. Dementia (GPs assessment) [less than score 26 in Mini Mental State Examination (MMSE)]
4. Psychosis
5. Severe sight disorder or auditory defect
6. Alcohol-or drug abuse
7. Dementia (less than score 26 in MMSE)
8. Residence in institutions e.g. nursing homes or residential care home
9. Visits at the practice of the GP not possible, home visits required
10. Alcohol-or drug abuse
11. Participation in a clinical trial within the last 30 days

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Johann Wolfgang Goethe University

Sponsor information


Federal Ministry of Education and Research (Germany)

Sponsor details

Dienstsitz Berlin
Hannoversche Straße 28-30
+49 (0)30 18 57 - 0

Sponsor type




Funder type


Funder name

Federal Ministry of Education and Research (Germany) ref: 01GY1145

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype




Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in:

Publication citations

  1. Results

    Ulrich LR, Mergenthal K, Petersen JJ, Roehl I, Rauck S, Kemperdick B, Schulz-Rothe S, Berghold A, Siebenhofer A, Anticoagulant treatment in German family practices - screening results from a cluster randomized controlled trial., BMC Fam Pract, 2014, 15, 170, doi: 10.1186/s12875-014-0170-0.

Additional files

Editorial Notes