Trial document



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  DRKS00010514

Trial Description

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Title

Adherence to lipid-lowering therapy after cardiac rehabilitation

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Trial Acronym

LLT-R-Registry

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URL of the Trial

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Brief Summary in Lay Language

During inpatient hospital stay for cardiac rehabilitation a medical treatment plan is established to contribute, inter alia, for lowering blood lipid levels. Impaired blood lipid levels are known risk factors for cardiovascular disease. Drug based treatment (for example, lipid-lowering substances = statins) leads to the optimization of lipid metabolism and reduces the likelihood of re-events such as heart attack or stroke. The aim of this study is to verify the compliance with the medical treatment plan prescribed in the medical discharge report and the blood fat levels in the further course. The participantion will not have an influence on the therapy decision. There will be no difference in the course of therapy from that of a non - study participant.

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Brief Summary in Scientific Language

In the western industrialized nations a large proportion of morbidity and mortality is associated with Coronary heart disease (CHD). The treatment of CHD is based on the the prevention of risk factors such as diabetes, hypertension, smoking and obesity. There is evidence that treatment with platelet inhibitors, ACE inhibitors, beta-blockers and in particular lipid-lowering substances may increase the life expectancy and quality of life of CHD patients. The most important drugs for evidence-based lipid-lowering treatment (LLT) of CHD are statins. The goal of this treatment is to reach a LDL cholesterol value of less than 1.8 mmol/L or, if not achievable, a reduction of 50 %. However, a poor patient compliance is a serious problem in taking lipid-lowering treatment during the therapy of patients with coronary heart disease. The aim of this study is to verify the compliance with the medical treatment plan prescribed in the medical discharge report and the blood fat levels in the further course.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010514
  •   2016/05/13
  •   2016/04/22
  •   yes
  •   Approved
  •   16/16, Ethik-Kommission der Ärztekammer Sachsen-Anhalt Bezirksstelle Halle
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Secondary IDs

  •   NCT02749279   (clinicaltrials.gov)
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Health Condition or Problem studied

  •   Coronary Heart Disease
  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   After discharge of patients from the rehabilitation questions regarding to the drug treatment will be evaluated during the following 12 months by use of a patient diary. It has to be documented whether the drug plan has changed and if so, why and who (physician, patient) made ​​the change. In addition, questions with particular reference to the lipid-lowering therapy will be collected after 3 and 12 months based on a questionnaire .
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Adherence to the recommended medication plan at discharge derived from the question, whether treatment plan was changed within 12 months since leaving the clinic (yes or no).

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Secondary Outcome

1. Reason for the changes to the drug plan determined by the question whether the change(s) were made by the physician or by the patient.

2. Reason for the changes to the drug plan determined by the question whether the change(s) to the drug plan was induced by an intolerance to the drug pruduct.

3. Reaching of the treatment goal of lipid -lowering therapy during the rehabilitation stay, as measured by the LDL Cholesterien value (< 1.8 mmol/l = 70 mg/dl)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/04
  •   1100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age ≥ 18 years
- Coronary Heard Disease
- lipid-lowering therapy
- inpatient hospital stay in one of the recruiting sites

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Exclusion Criteria

- Lack of informed consent
- Diseases or disorders that may prevent a participation to this study according to the investigators judgement (dementia, psychotic disorders)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Paracelsus-Harz-KlinikKardiologie, Pneumologie, Diabetes
    • Mr.  Prof. Dr. med.  Axel  Schlitt 
    • Paracelsusstraße 1
    • 06485  Quedlinburg
    • Germany
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    • Martin Luther-Universität Halle-Wittenberg Medizinische Fakultät Koordinierungszentrum für Klinische Studien
    • Mr.  Dr. sc. nat.  Michael  Richter 
    • 06097  Halle (Saale)
    • Germany
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    • Paracelsus-Harz-KlinikKardiologie, Pneumologie, Diabetes
    • Mr.  Prof. Dr. med.  Axel  Schlitt 
    • Paracelsusstraße 1
    • 06485  Quedlinburg
    • Germany
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    • Paracelsus-Harz-KlinikKardiologie, Pneumologie, Diabetes
    • Mr.  Prof. Dr. med.  Axel  Schlitt 
    • Paracelsusstraße 1
    • 06485  Quedlinburg
    • Germany
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Sources of Monetary or Material Support

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    • Sanofi-Aventis Deutschland GmbH
    • 10785  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/01/31
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Trial Publications, Results and other Documents

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