AtherosclerosisVienna REACTNCT00858715
Resistance to Antithrombotic Therapy
A study testing aspirin and clopidogrel in people with Atherosclerosis and Angioplasty, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Angioplasty
- What is being tested?
- aspirin and clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to May 2012
- Phase
- Interventional
- 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
Who may be able to join
- written informed consent
- angioplasty and stenting for peripheral, coronary or carotid artery disease
Who cannot join
- known aspirin or clopidogrel intolerance
- therapy with vitamin K antagonists (warfarin, phenprocoumon, acenocoumarol)
- treatment with ticlopidine, dipyridamol or nonsteroidal antiinflammatory drugs
- family or personal history of bleeding disorders
- malignant paraproteinemias
- myeloproliferative disorders
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- heparin-induced thrombocytopenia
- severe hepatic failure
- known qualitative defects in thrombocyte function
- major surgical procedure within one week before enrollment
- platelet count < 100.000 or > 450.000/µl
- hemoglobin < 8 g/dl
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Angiology, Department of Internal Medicine II, Medical University of Vienna
Vienna, 1090
About this study
Official title: Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT
Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for adverse events after coronary stenting. In the present study, platelet reactivity will be determined by 6 different platelet function tests in patients on dual antiplatelet therapy after angioplasty and stenting for peripheral, coronary and carotid artery disease. One hundred patients showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for 3 months. The aim of the present study is to investigate the effects of intensified antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased clopidogrel-mediated platelet inhibition after percutaneous intervention with stent implantation.
- Conditions
- Atherosclerosis, Angioplasty
- Being tested
- aspirin, clopidogrel
- Keywords
- Clopidogrel, Aspirin, Antithrombotic therapy, Platelet function testing
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
100 mg aspirin
clopidogrelDrug
75 mg (Arm 1) and 150 mg (Arm 2)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 75 mg clopidogrel + 100 mg aspirin Receives: Drug: aspirin; Drug: clopidogrel |
| 2 | Active comparator | 150 mg clopidogrel + 100 mg aspirin Receives: Drug: aspirin; Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of major adverse cardiovascular events (MACE)
Measured: 3 months
Occurence of major adverse cardiovascular events (MACE)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph W. Kopp, Medical University of Vienna
- Investigators
- Christoph W. Kopp, M.D., Principal investigator, Division of Angiology/ Department of Internal Medicine II/ Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858715
- Sponsor's protocol ID
- Vienna REACT
- Acronym
- Vienna REACT
- Status last verified
- Dec 2012
- First submitted
- 9 Mar 2009
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT
- ClinicalTrials.gov ID
- NCT00858715
- Acronym / sponsor ID
- Vienna REACT / Vienna REACT
- Conditions
- Atherosclerosis, Angioplasty
- Keywords
- Clopidogrel, Aspirin, Antithrombotic therapy, Platelet function testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Mar 2009 (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.
Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for adverse events after coronary stenting. In the present study, platelet reactivity will be determined by 6 different platelet function tests in patients on dual antiplatelet therapy after angioplasty and stenting for peripheral, coronary and carotid artery disease. One hundred patients showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for 3 months. The aim of the present study is to investigate the effects of intensified antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased clopidogrel-mediated platelet inhibition after percutaneous intervention with stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: aspirin, Drug: clopidogrel75 mg clopidogrel + 100 mg aspirin |
| 2 | Active comparator | Drug: aspirin, Drug: clopidogrel150 mg clopidogrel + 100 mg aspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written informed consent
- angioplasty and stenting for peripheral, coronary or carotid artery disease
Key exclusion criteria (12 listed)
- known aspirin or clopidogrel intolerance
- therapy with vitamin K antagonists (warfarin, phenprocoumon, acenocoumarol)
- treatment with ticlopidine, dipyridamol or nonsteroidal antiinflammatory drugs
- family or personal history of bleeding disorders
- malignant paraproteinemias
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 |
|---|---|---|
| aspirin100 mg aspirin | Drug | 1, 2 |
| clopidogrel75 mg (Arm 1) and 150 mg (Arm 2) | Drug | 1, 2 |
Primary outcome
Occurence of major adverse cardiovascular events (MACE)
Time frame: 3 months
Occurence of major adverse cardiovascular events (MACE)
Time frame: 12 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 12 Dec 2012.
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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.
Christoph W. Kopp, M.D. principal investigator
Division of Angiology/ Department of Internal Medicine II/ Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspirin and clopidogrel in people with Atherosclerosis and Angioplasty, run by Medical University of Vienna at 1 site in Austria.
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 12 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 12 Dec 2012. 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 Austria. 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?
Occurence of major adverse cardiovascular events (MACE) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 12 Dec 2012.