NCT01417884

Brief Summary

Molecular targets on platelets are pivotal for the development of new pharmacological substrates for platelet inhibition and to better understand the impact of platelet-mediated inflammatory processes for the progression of heart disease, such as coronary heart disease and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19 encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs. Therefore, a prospective patient cohort with exact phenotypic characterisation according to standardized protocols is necessary to enable the examination of the clinical relevance of potential molecular targets. A supplementary provision of high quality bio-material enables the systematic examination of new promising platelet-biomarkers in cardiovascular disease, which already have produced significant results on experimental animal and/or cell biologic models. Primary objective of the central project is to establish a prospective cardiological cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated Biobank and thus to review the clinical significance of potential targets deriving from individual subprojects within the research group (German Research Council KFO 274/1-1) to safeguard a translational approach.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

8.9 years

First QC Date

August 12, 2011

Last Update Submit

October 10, 2018

Conditions

Cardiovascular Disease

Keywords

molecular cardiologymolecular epidemiologyplateletscardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Mortality

    4 years

Secondary Outcomes (5)

  • Cardiovascular Death

    4 years

  • Myocardial infarction

    4 years

  • ischemic stroke

    4 years

  • bleeding

    4 years

  • stent thrombosis

    4 years

Study Arms (2)

ischemic heart disease

stable coronary artery disease, acute coronary syndromes

non-ischemic heart disease

inflammatory heart disease, heart failure (non-ischemic), valvular heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In-hospital patients and outpatients

You may qualify if:

  • Patients with ischemic and non-ischemic heart disease
  • informed consent by patients or relatives in case of missing capacity to consent due to health status

You may not qualify if:

  • Patients \<18 years
  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik und Poliklinik Tübingen, Cardiology Department, University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Related Publications (1)

  • Borst O, Munzer P, Alnaggar N, Geue S, Tegtmeyer R, Rath D, Droppa M, Seizer P, Heitmeier S, Heemskerk JWM, Jennings LK, Storey RF, Angiolillo DJ, Rocca B, Spronk H, Ten Cate H, Gawaz M, Geisler T. Inhibitory mechanisms of very low-dose rivaroxaban in non-ST-elevation myocardial infarction. Blood Adv. 2018 Mar 27;2(6):715-730. doi: 10.1182/bloodadvances.2017013573.

    PMID: 29588304DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, salivatory

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Tobias Geisler, Prof. Dr.

    UKT

    PRINCIPAL INVESTIGATOR

  • Matthias Schwab, Prof. Dr.

    UKT, IKP Stuttgart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Geisler, Prof. Dr.

CONTACT

+49 7071 29 82712tobias.geisler@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 16, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2020

Study Completion

December 1, 2025

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

DE(1)