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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02148939
Other study ID # Stroke
Secondary ID
Status Completed
Phase N/A
First received May 16, 2014
Last updated March 9, 2015
Start date May 2014
Est. completion date February 2015

Study information

Verified date March 2015
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Many patients suffer from acute and chronic pain. The incidence of chronic pain correlates with increased age. Most of patients rely on analgesic medication to control the pain. Dipyrone is an extensively used drug in Western and Eastern Europe as well as Central and South America, largely due to its favorable analgesic and antipyretic effects in conjunction with a low incidence of gastrointestinal complications when compared to other non-steroidal anti-inflammatory drugs (NSAIDs).

Aspirin is the backbone of antiplatelet therapy in patients after ischemic stroke. However, it is known that there are substantial inter-individual response variabilities to antiplatelet medication. Furthermore, patients with impaired response to aspirin have a significant higher risk of recurrent cerebrovascular events. The investigators have recently shown that co-medication with aspirin and dipyrone in patients with coronary artery disease lead to insufficient antiplatelet effects of aspirin.

The incidence of chronic pain is very high in patients with ischemic stroke. Therefore, in this study the investigators aim to examine, if co-medication of aspirin and dipyrone interaction also occurs in patients after ischemic stroke.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18 years

- Patients with ischemic stroke and ASS-medication (80-320 mg/day) with/without analgesic comedication

Exclusion Criteria:

- Reanimation

- cardiogenic shock

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Division of Cardiology, Pulmonary Disease and Vascular Medicine Düsseldorf

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 Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients Baseline No
Secondary Major adverse cardiac and cerebrovascular events (MACCE Events) during hospital stay participants are followed until discharge up to 4 weeks No
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