Peripheral Arterial Occlusive DiseaseNCT00593762
ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures
An observational study of Peripheral Arterial Occlusive Disease, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in patients with peripheral arterial occlusive disease (PAOD) requiring interventional procedures and to investigate if patients with "resistance" to ASA or Clopidogrel have an unfavourable outcome during long-term follow-up Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Dec 2009
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with peripheral arterial occlusive disease (PAOD) requiring a catheter interventional procedure
Who may be able to join
- PAOD patients
- Age 18-85 years
- Need for a catheter interventional procedure
- Antithrombotic therapy with aspirin or clopidogrel
Who cannot join
- Comedication additionally compromising platelet function
- Known bleeding disorder
- Life expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital
Frankfurt am Main, Hesse, D-60590
About this study
Official title: Investigation of Laboratory Resistance to Aspirin and Clopidogrel and Its Clinical Relevance in Patients With Peripheral Arterial Occlusive Disease Requiring Interventional Procedures
The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in patients with peripheral arterial occlusive disease (PAOD) requiring interventional procedures and to investigate if patients with "resistance" to ASA or Clopidogrel have an unfavourable outcome during long-term follow-up
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Peripheral arterial occlusive disease, Aspirin, Clopidogrel, Resistance, Catheter interventional procedure, ASA and clopidogrel resistance
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for peripheral arterial revascularisation
Measured: 1, 6, 12 and 24 months
Secondary outcomes (1)
Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI)
Measured: 1, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMay 2005
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Birgit Linnemann, MD, Principal investigator, Division of Vascular Medicine, Department of Internal Medicine, J.W. Goethe University Hospital Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593762
- Sponsor's protocol ID
- E 19/05
- Status last verified
- Jan 2008
- First submitted
- 3 Jan 2008
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Laboratory Resistance to Aspirin and Clopidogrel and Its Clinical Relevance in Patients With Peripheral Arterial Occlusive Disease Requiring Interventional Procedures
- ClinicalTrials.gov ID
- NCT00593762
- Acronym / sponsor ID
- E 19/05
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Peripheral arterial occlusive disease, Aspirin, Clopidogrel, Resistance, Catheter interventional procedure, ASA and clopidogrel resistance
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 15 Jan 2008 (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.
The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in patients with peripheral arterial occlusive disease (PAOD) requiring interventional procedures and to investigate if patients with "resistance" to ASA or Clopidogrel have an unfavourable outcome during long-term follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with peripheral arterial occlusive disease (PAOD) requiring a catheter interventional procedure
Key inclusion criteria (4 listed)
- PAOD patients
- Age 18-85 years
- Need for a catheter interventional procedure
- Antithrombotic therapy with aspirin or clopidogrel
Key exclusion criteria (3 listed)
- Comedication additionally compromising platelet function
- Known bleeding disorder
- Life expectancy < 6 months
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
Need for peripheral arterial revascularisation
Time frame: 1, 6, 12 and 24 months
1 secondary outcome
Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI)
Time frame: 1, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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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.
Birgit Linnemann, MD principal investigator
Division of Vascular Medicine, Department of Internal Medicine, J.W. Goethe University Hospital Frankfurt
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 Peripheral Arterial Occlusive Disease, run by Johann Wolfgang Goethe University Hospital 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 4 inclusion and 3 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: paused, as of the sponsor's last update on 16 Mar 2010. 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?
Results are not available in the source record.
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?
Need for peripheral arterial revascularisation (time frame: 1, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2010.