CADNCT01402804
NSAIDs in Coronary Artery Disease Patients
An observational study of CAD, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jul 2013
- 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 a stable CAD undergoing coronary angiography in the Universitätsklinik Düsseldorf.
Who may be able to join
- Patients on a simultaneous ASA, NSAID treatment
- > 18 years
Who cannot join
- unconsciousness, not able to consent
- reanimation, cardiac shock
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Non-steroidal Anti-inflammatory Drugs Impair the Platelet Inhibiting Effect of Acetylsalicylic Acid in Coronary Artery Disease Patients
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.
- Conditions
- CAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stable CAD, ASA, NSAID | Not described | |
| Stable CAD, ASA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid
Measured: During hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionJul 2013
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 CADStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 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 Kariologie, Pneumologie und Angiologie, Universtiätsklinikum DüsseldorfTobias Zeus, MD, Study chair, Klinik für Kardiologie, Pneumologie und AngiologieThomas Hohlfeld, MD, Study chair, Institut für Pharmakologie und Klinische Pharmakologie, Heinrich-Heine-Univerität DüsseldorfMalte Kelm, MD, Study director, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402804
- Sponsor's protocol ID
- AGP-0001
- Status last verified
- Nov 2013
- First submitted
- 25 Jul 2011
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Achilles A, Mohring A, Dannenberg L, Piayda K, Levkau B, Hohlfeld T, Zeus T, Kelm M, Polzin A. Analgesic medication with dipyrone in patients with coronary artery disease: Relation to MACCE. Int J Cardiol. 2017 Jun 1;236:76-81. doi: 10.1016/j.ijcard.2017.02.122. Epub 2017 Feb 27.
PubMed 28262342
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-steroidal Anti-inflammatory Drugs Impair the Platelet Inhibiting Effect of Acetylsalicylic Acid in Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT01402804
- Acronym / sponsor ID
- AGP-0001
- Conditions
- CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jul 2011 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable CAD, ASA, NSAID | – | – |
| Stable CAD, ASA | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a stable CAD undergoing coronary angiography in the Universitätsklinik Düsseldorf.
Key inclusion criteria (2 listed)
- Patients on a simultaneous ASA, NSAID treatment
- > 18 years
Key exclusion criteria (2 listed)
- unconsciousness, not able to consent
- reanimation, cardiac 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
Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid
Time frame: During hospital stay
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 11 Nov 2013.
- Derived from this study: PubMed 28262342Achilles A, Mohring A, Dannenberg L, Piayda K, Levkau B, Hohlfeld T, Zeus T, Kelm M, Polzin A. Analgesic medication with dipyrone in patients with coronary artery disease: Relation to MACCE. Int J Cardiol. 2017 Jun 1;236:76-81. doi: 10.1016/j.ijcard.2017.02.122. Epub 2017 Feb 27.
- 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 Kariologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
Tobias Zeus, MD study chair
Klinik für Kardiologie, Pneumologie und Angiologie
Thomas Hohlfeld, MD study chair
Institut für Pharmakologie und Klinische Pharmakologie, Heinrich-Heine-Univerität 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 CAD, 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 11 Nov 2013. 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?
Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid (time frame: During hospital stay). 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 NCT01402804, 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 11 Nov 2013.