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Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry (PERI-DYS)

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ClinicalTrials.gov Identifier: NCT03110432
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

Brief Summary:
This is a prospective German registry for patients with dyslipidemia with very high cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are treated by office-based cardiologists or in lipid ambulances.

Condition or disease Intervention/treatment
Dyslipoproteinemias Drug: PCSK9 Inhibitor [EPC] Drug: Standard lipid lowering therapy

Detailed Description:

The study is purely observational, and will document data from the patient charts only. Treatment of patients will not be changed by this study, and all clinical decisions (including on frequency of visits) will be upon the discretion of the physician. No blood samples must be taken solely for the purpose of the study.

The registry will include two types of centers: 1) office-based cardiologists and 2) specialized lipid ambulances (outpatient departments).

Data on patient disease and treatment history will be collected a first documentation (retrospectively).

The documentation time is 3 years per patient. After the baseline visit, patients are followed-up every 6 ± 2months (last visit at month 36). This interval is considered narrow enough not to miss important events (safety reporting, cardiovascular events, hospitalizations).

Patients with stable (maintenance) lipid-lowering therapy (including those with existing PCSK9i therapy) or those with any therapy changes (including newly initiated PCSK9i treatment) will be documented in this study. Compared to the former group with stable drug treatment, the latter group will likely have major LDL-C changes during the first few weeks, which will be accounted for by (retrospective) monthly documentation in the first 3 months (data will be documented at the 6-month visit.

The documentation periods will be substantially longer than in the controlled studies of the PCSK9i (endpoints were as early as 3 months), and thus will provide much-needed information about the long-term effects on LDL-C and other lipid parameters, safety, and drug retention rates. Longer follow-up periods would likely be compromised by high rates of (administrative) discontinuation rates.


Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : February 16, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Standard lipid lowering therapy
Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids (and any combinations of these agents)
Drug: Standard lipid lowering therapy
drug use according to the respective product labelling
Other Name: Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids

PCSK9 Inhibitor [EPC]
Evolocumab or alirocumab.
Drug: PCSK9 Inhibitor [EPC]
drug use according to the respective product labelling
Other Name: Repatha, Praluent




Primary Outcome Measures :
  1. LDL cholesterol goal achievement [ Time Frame: 3 years ]
    < 70 mg/dl


Secondary Outcome Measures :
  1. LDL cholesterol reduction [ Time Frame: up top 3 years ]
    Compared to baseline

  2. Number of treatment changes [ Time Frame: up to 3 years ]
    During the follow-up period


Other Outcome Measures:
  1. Change in quality of life [ Time Frame: up to 3 years ]
    by EuroQol 5 dimensions



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with dyslipidemia and very high cardiovascular risk ("highest risk patients" according to G-BA stipulation for PCSK9i use)
Criteria

Inclusion Criteria:

  • • with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or

    • with confirmed familial, heterozygous hypercholesterolemia under consideration of the total familial risk, or
    • with heterozygous familial or non‐ familial hypercholesterolemia or mixed dyslipidemia with

      • therapy refractory course
      • maximal dietary and pharmaceutical lipid lowering therapy - in any case documented over a 12-month period
      • unsatisfactorily lowered LDL-C value (and thus with an indication for LDL apheresis)
      • confirmed vascular disease
      • other risk factors for cardiovascular events

Exclusion Criteria:

  • Concurrent participation of the patient in a clinical randomised study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110432


Contacts
Contact: David Pittrow, MD +49 351 25933 ext 182 david.pittrow@mailbox.tu-dresden.de
Contact: Romy Hoppenz +49 351 25933 ext 182 romy.hoppenz@gwtonline.de

Locations
Germany
Medizinische Klinik und Poliklinik III Recruiting
Dresden, Germany
Contact: Andreas Birkenfeld, MD         
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Principal Investigator: David Pittrow, MD, PhD GWT-TUD
Study Chair: Andreas Birkenfeld, MD GWT-TUD
Study Chair: Bernd Hohenstein, MD Faculty of Medicine Carl Gustav Carus, Dresden
Study Chair: Ulrich Laufs, MD linik für Innere Medizin III, Universität des Saarlandes
Study Chair: Volker Schettler, MD Apheresis Centre, Nehrologisches Zentrum Göttingen GbR
Study Chair: Elisabeth Steinhagen-Thiessen, MD Lipid Clinic, Charité, University of Berlin
Study Director: Uwe Fraass, MD Amgen Pharma, Munich
Study Director: Stephan Kropff, MD Amgen Pharma, Munich

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT03110432     History of Changes
Other Study ID Numbers: PERI-DYS
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Colesevelam Hydrochloride
Niacin
Nicotinic Acids
Niacinamide
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents