Stable Angina PectorisPhase 3DOSERNCT00638326
Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity
A Phase 3 study testing clopidogrel in people with Stable Angina Pectoris and Ad Hoc Percutaneous Coronary Intervention, run by University of Pecs at 1 site in Hungary.
Trial summary
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stable Angina Pectoris, Ad Hoc Percutaneous Coronary Intervention
- What is being tested?
- clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2008to Mar 2010
- Phase
- Phase 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clopidogrel-naïve stable angina pectoris (CCS I-III)
- Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation
Who cannot join
- Acute coronary syndrome (STEMI, NSTEMI or unstable angina)
- Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks
- Contraindication to antiplatelet therapy
- Significant LM stenosis
- PCI due to instent restenosis
- Lesion located in bypass grafts
- Stroke in past one year
- Reduced life expectancy
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Heart Institute, University of Pécs, Dept. of Interventional Cardiology
Pécs, 7624
About this study
Official title: 150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.
- Being tested
- clopidogrel, clopidogrel plus placebo
- Keywords
- Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents
- Medical subject headings
- Angina, Stable, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
clopidogrel plus placeboDrug
75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel |
| 2 | Experimental | Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days Receives: Drug: clopidogrel |
| 3 | Active comparator | Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel Receives: Drug: clopidogrel plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.
Measured: 12 months
Secondary outcomes (5)
Academic Research Consortium (ARC) definite / probable stent thrombosis
Measured: 12 months
Cardiac death and non-fatal myocardial infarction
Measured: 12 months
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding
Measured: 12 months
5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer
Measured: 25 +/-2 days
VASP-PRI
Measured: 25 +/-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionMar 2010
Why it stopped: Greater differences between randomized patients than previously anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable Angina PectorisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Investigators
- Ivan G Horvath, MD PhD, Principal investigator, Heart Institute, University of Pécs, HUNGARYDaniel Aradi, MD, Study director, Heart Institute, University of Pécs, HUNGARYAndras Komocsi, MD PhD, Study chair, Heart Institute, University of Pécs, HUNGARY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638326
- Sponsor's protocol ID
- Pecs-001
- Acronym
- DOSER
- Status last verified
- Mar 2010
- First submitted
- 11 Mar 2008
- Last updated
- 23 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aradi D, Rideg O, Vorobcsuk A, Magyarlaki T, Magyari B, Konyi A, Pinter T, Horvath IG, Komocsi A. Justification of 150 mg clopidogrel in patients with high on-clopidogrel platelet reactivity. Eur J Clin Invest. 2012 Apr;42(4):384-92. doi: 10.1111/j.1365-2362.2011.02594.x. Epub 2011 Sep 9.
PubMed 21902692Rideg O, Komocsi A, Magyarlaki T, Tokes-Fuzesi M, Miseta A, Kovacs GL, Aradi D. Impact of genetic variants on post-clopidogrel platelet reactivity in patients after elective percutaneous coronary intervention. Pharmacogenomics. 2011 Sep;12(9):1269-80. doi: 10.2217/pgs.11.73. Epub 2011 Aug 1.
PubMed 21806387
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00638326
- Acronym / sponsor ID
- DOSER / Pecs-001
- Keywords
- Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Greater differences between randomized patients than previously anticipated
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Mar 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 whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel |
| 2 | Experimental | Drug: clopidogrelPatients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days |
| 3 | Active comparator | Drug: clopidogrel plus placeboPatients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clopidogrel-naïve stable angina pectoris (CCS I-III)
- Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation
Key exclusion criteria (8 listed)
- Acute coronary syndrome (STEMI, NSTEMI or unstable angina)
- Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks
- Contraindication to antiplatelet therapy
- Significant LM stenosis
- PCI due to instent restenosis
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 |
|---|---|---|
| clopidogrel150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year | Drug | 2 |
| clopidogrel plus placebo75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year | Drug | 3 |
Primary outcome
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.
Time frame: 12 months
5 secondary outcomes
Academic Research Consortium (ARC) definite / probable stent thrombosis
Time frame: 12 months
Cardiac death and non-fatal myocardial infarction
Time frame: 12 months
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding
Time frame: 12 months
5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer
Time frame: 25 +/-2 days
VASP-PRI
Time frame: 25 +/-2 days
Results and safety
The study was stopped early (reason given: Greater differences between randomized patients than previously anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2010.
- Derived from this study: PubMed 21902692Aradi D, Rideg O, Vorobcsuk A, Magyarlaki T, Magyari B, Konyi A, Pinter T, Horvath IG, Komocsi A. Justification of 150 mg clopidogrel in patients with high on-clopidogrel platelet reactivity. Eur J Clin Invest. 2012 Apr;42(4):384-92. doi: 10.1111/j.1365-2362.2011.02594.x. Epub 2011 Sep 9.
- Derived from this study: PubMed 21806387Rideg O, Komocsi A, Magyarlaki T, Tokes-Fuzesi M, Miseta A, Kovacs GL, Aradi D. Impact of genetic variants on post-clopidogrel platelet reactivity in patients after elective percutaneous coronary intervention. Pharmacogenomics. 2011 Sep;12(9):1269-80. doi: 10.2217/pgs.11.73. Epub 2011 Aug 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.
Ivan G Horvath, MD PhD principal investigator
Heart Institute, University of Pécs, HUNGARY
Daniel Aradi, MD study director
Heart Institute, University of Pécs, HUNGARY
Andras Komocsi, MD PhD study chair
Heart Institute, University of Pécs, HUNGARY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clopidogrel in people with Stable Angina Pectoris and Ad Hoc Percutaneous Coronary Intervention, run by University of Pecs at 1 site in Hungary.
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 8 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: stopped early, as of the sponsor's last update on 23 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 Hungary. 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.
What does this phase mean?
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 was stopped early (reason given: Greater differences between randomized patients than previously anticipated). 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?
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation. (time frame: 12 months). 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 NCT00638326, which also lists 2 linked publications.
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 23 Mar 2010.