Antiplatelet Effects in Stroke-Patients

March 9, 2015 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Dipyrone Nullifies Aspirin Antiplatelet Effects in Stroke-Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with ischemic stroke

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac and cerebrovascular events (MACCE Events) during hospital stay
Time Frame: participants are followed until discharge up to 4 weeks
participants are followed until discharge up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Amin Polzin, MD, Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
  • Study Chair: Tobias Zeus, MD, Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • stroke

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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