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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01402804
Other study ID # AGP-0001
Secondary ID
Status Completed
Phase N/A
First received July 25, 2011
Last updated November 8, 2013
Start date July 2011
Est. completion date July 2013

Study information

Verified date November 2013
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients on a simultaneous ASA, NSAID treatment

- > 18 years

Exclusion Criteria:

- unconsciousness, not able to consent

- reanimation, cardiac shock

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Germany Heinrich-Heine-University Düsseldorf NRW

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid During hospital stay No
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