Ischemic StrokeNCT02148939
Antiplatelet Effects in Stroke-Patients
An observational study of Ischemic Stroke, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with ischemic stroke
Who may be able to join
- Age ≥ 18 years
- Patients with ischemic stroke and ASS-medication (80-320 mg/day) with/without analgesic comedication
Who cannot join
- Reanimation
- cardiogenic shock
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: 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.
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, Antiplatelet Effects, aspirin, metamizole, dipyrone
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients
Measured: Baseline
Secondary outcomes (1)
Major adverse cardiac and cerebrovascular events (MACCE Events) during hospital stay
Measured: participants are followed until discharge up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Amin Polzin, MD, Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum DüsseldorfTobias Zeus, MD, Study chair, Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148939
- Sponsor's protocol ID
- Stroke
- Status last verified
- Mar 2015
- First submitted
- 16 May 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27301652
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipyrone Nullifies Aspirin Antiplatelet Effects in Stroke-Patients
- ClinicalTrials.gov ID
- NCT02148939
- Acronym / sponsor ID
- Stroke
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, Antiplatelet Effects, aspirin, metamizole, dipyrone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ischemic stroke
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients with ischemic stroke and ASS-medication (80-320 mg/day) with/without analgesic comedication
Key exclusion criteria (2 listed)
- Reanimation
- cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients
Time frame: Baseline
1 secondary outcome
Major adverse cardiac and cerebrovascular events (MACCE Events) during hospital stay
Time frame: participants are followed until discharge up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 27301652Dannenberg 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin Polzin, MD principal investigator
Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
Tobias Zeus, MD study chair
Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.