Peripheral Vascular DiseasesPhase 2/3NCT00163267
Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
A Phase 2/3 study testing clopidogrel in people with Peripheral Vascular Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Apr 2011
- Phase
- Phase 2/3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral arterial disease which requires intervention
Who cannot join
- Patient already on coumadin or clopidogrel
- Acute onset of PVD symptoms
- Patient requiring an operation
- Contraindication to aspirin and clopidogrel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study
The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.
Read the detailed description
Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact.
Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- clopidogrel
- Keywords
- peripheral arterial intervention, atherosclerosis, platelets, Age above 18
- Medical subject headings
- Peripheral Vascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Best endovascular treatment either with one or the other drug arm should be investigated
| Study group | Role | What they receive |
|---|---|---|
| ASS + Placebo | Placebo comparator | control arm Receives: Drug: clopidogrel |
| ASS + Plavix | Active comparator | active drug Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation during and after the intervention
measured in a chandler loop model
Measured: 6-12 hours
Secondary outcomes (4)
ABI
as treatment effect
Measured: before patients leaves the hospital and at 6 months
clinical improvement
dependent on the additional drug treatment
Measured: up to 6 months
Safety
dependent on the drug treatment with the endovascular treatment
Measured: up to 6 months
rate of occlusions
dependent on drug treatment
Measured: wihtin 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionApr 2011
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 Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Gunnar Tepe, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163267
- Sponsor's protocol ID
- mi-1
- Other IDs
- D.3100340
- Status last verified
- Apr 2007
- First submitted
- 8 Sep 2005
- Last updated
- 9 Aug 2011
- Results posted
- No
Publications
Strobl FF, Brechtel K, Schmehl J, Zeller T, Reiser MF, Claussen CD, Tepe G. Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease. J Endovasc Ther. 2013 Oct;20(5):699-706. doi: 10.1583/13-4275MR.1.
PubMed 24093324
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study
- ClinicalTrials.gov ID
- NCT00163267
- Acronym / sponsor ID
- mi-1
- Conditions
- Peripheral Vascular Diseases
- Keywords
- peripheral arterial intervention, atherosclerosis, platelets, Age above 18
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Sep 2005 (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 Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.
Detailed description
Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact.
Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASS + Placebo | Placebo comparator | Drug: clopidogrelcontrol arm |
| ASS + Plavix | Active comparator | Drug: clopidogrelactive drug |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peripheral arterial disease which requires intervention
Key exclusion criteria (4 listed)
- Patient already on coumadin or clopidogrel
- Acute onset of PVD symptoms
- Patient requiring an operation
- Contraindication to aspirin and clopidogrel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrelBest endovascular treatment either with one or the other drug arm should be investigated | Drug | ASS + Placebo, ASS + Plavix |
Primary outcome
Platelet activation during and after the intervention
Time frame: 6-12 hours
measured in a chandler loop model
4 secondary outcomes
ABI
Time frame: before patients leaves the hospital and at 6 months
clinical improvement
Time frame: up to 6 months
Safety
Time frame: up to 6 months
rate of occlusions
Time frame: wihtin 6 months
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 9 Aug 2011.
- Derived from this study: PubMed 24093324Strobl FF, Brechtel K, Schmehl J, Zeller T, Reiser MF, Claussen CD, Tepe G. Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease. J Endovasc Ther. 2013 Oct;20(5):699-706. doi: 10.1583/13-4275MR.1.
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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.
Gunnar Tepe, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing clopidogrel in people with Peripheral Vascular Diseases, run by University Hospital Tuebingen 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 1 inclusion and 4 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 9 Aug 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Platelet activation during and after the intervention (time frame: 6-12 hours). 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 NCT00163267, 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 9 Aug 2011.