NCT02148939

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

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

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

May 16, 2014

Last Update Submit

March 9, 2015

Conditions

Keywords

ischemic strokeAntiplatelet Effectsaspirinmetamizoledipyrone

Outcome Measures

Primary Outcomes (1)

  • Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients

    Baseline

Secondary Outcomes (1)

  • Major adverse cardiac and cerebrovascular events (MACCE Events) during hospital stay

    participants are followed until discharge up to 4 weeks

Eligibility Criteria

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

patients with ischemic stroke

You may qualify if:

  • Age ≥ 18 years
  • Patients with ischemic stroke and ASS-medication (80-320 mg/day) with/without analgesic comedication

You may not qualify if:

  • Reanimation
  • cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Related Publications (1)

  • Dannenberg L, Erschoff V, Bonner F, Gliem M, Jander S, Levkau B, Kelm M, Hohlfeld T, Zeus T, Polzin A. Dipyrone comedication in aspirin treated stroke patients impairs outcome. Vascul Pharmacol. 2016 Dec;87:66-69. doi: 10.1016/j.vph.2016.06.003. Epub 2016 Jun 11.

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Amin Polzin, MD

    Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf

    PRINCIPAL INVESTIGATOR
  • Tobias Zeus, MD

    Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 29, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations