NCT01402804

Brief Summary

Introduction: Different groups already showed in retrospective subgroup analyses, that there is an increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment. Methods: Light-Transmission aggregometry Hypothesis: Simultaneous administration of different NSAIDs and ASA impair the platelet inhibiting effect of ASA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

July 25, 2011

Last Update Submit

November 8, 2013

Conditions

CAD

Outcome Measures

Primary Outcomes (1)

  • Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid

    During hospital stay

Study Arms (2)

Stable CAD, ASA, NSAID

Stable CAD, ASA

Eligibility Criteria

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

Patients with a stable CAD undergoing coronary angiography in the Universitätsklinik Düsseldorf.

You may qualify if:

  • Patients on a simultaneous ASA, NSAID treatment
  • \> 18 years

You may not qualify if:

  • unconsciousness, not able to consent
  • reanimation, cardiac shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

  • Achilles A, Mohring A, Dannenberg L, Piayda K, Levkau B, Hohlfeld T, Zeus T, Kelm M, Polzin A. Analgesic medication with dipyrone in patients with coronary artery disease: Relation to MACCE. Int J Cardiol. 2017 Jun 1;236:76-81. doi: 10.1016/j.ijcard.2017.02.122. Epub 2017 Feb 27.

    PMID: 28262342DERIVED

Related Links

Study Officials

  • Amin Polzin, MD

    Klinik für Kariologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf

    PRINCIPAL INVESTIGATOR

  • Tobias Zeus, MD

    Klinik für Kardiologie, Pneumologie und Angiologie

    STUDY CHAIR

  • Thomas Hohlfeld, MD

    Institut für Pharmakologie und Klinische Pharmakologie, Heinrich-Heine-Univerität Düsseldorf

    STUDY CHAIR

  • Malte Kelm, MD

    Heinrich-Heine University, Duesseldorf

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Klinik für Kardiologie, Pneumologie und Angiologie

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

DE(1)