Coronary Artery DiseasePhase 4OPTIDUALNCT00822536
Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation
A Phase 4 study testing Aspirin and Clopidogrel and Aspirin in people with Coronary Artery Disease and Stent Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Stent Thrombosis, Myocardial Ischemia
- What is being tested?
- Aspirin and Clopidogrel and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,798 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Sep 2014
- Phase
- Phase 4
- 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
- Patients on aspirin and clopidogrel therapy at 12 months after DES implantation
- Informed, written consent by the patient
Who cannot join
- DES in left main coronary artery
- Oral anticoagulation therapy with coumadin derivatives
- Active bleeding; bleeding diathesis; history intracranial bleeding
- Known allergy or intolerance to the study medications: aspirin and clopidogrel
- Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
- Patient's inability to fully comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation
To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.
Read the detailed description
Drug-eluting stents (DES) substantially reduce restenosis compared with bare metal stents and represent a significant advance in percutaneous coronary interventions (PCIs). Accordingly, DES have been rapidly adopted into practice and are currently used in the majority of PCI procedures. Despite their rapid acceptance, DES are not without limitations. In particular, patients who receive DES (like those who receive conventional bare metal stents) remain at risk of a 1% to 2% incidence of stent thrombosis, which is often associated with devastating consequences like death or myocardial infarction. Understanding and eliminating mediators of stent thrombosis are thus important goals for optimizing the clinical benefits of DES. Delayed endothelial coverage after DES implantation has been demonstrated and is thought to prolong the window of vulnerability to stent thrombosis. Consequently, current recommendations for DES are: dual antiplatelet therapy for at least 12 months in patients at low risk of bleeding, especially with " off-label " use. Because of rare but severe very late stent thrombosis, the dual antiplatelet therapy is more and more prescribed in clinical practice for several years.But it has been clearly demonstrated that the combination of aspirin and clopidogrel (the thienopyridine the most used) significantly increase the rate of severe and moderate bleedings when compared to aspirin alone. This is important if we consider the possibility or the necessity to prolong the combined antiplatelet therapy after stent implantation.ProposalTo compare treatment with aspirin alone versus the combined antiplatelet treatment with aspirin and clopidogrel after 12 months of combined antiplatelet treatment after DES implantation
NB : On the decision of the sponsor, the latest patient monitoring was advanced to September 30, 2014 instead of January 2015.
- Being tested
- Aspirin and Clopidogrel, Aspirin
- Keywords
- Drug-eluting stent, Clopidogrel, Stent thrombosis, Myocardial infarction
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin and ClopidogrelDrug
Also called Aspirin: acid acetylsalycilic, Clopidogrel: plavix
Aspirin <= 325 mg/j Clopidogrel = 75 mg /j
AspirinDrug
Also called Aspirin: acid acetylsalycilic
Aspirin : <= 325 mg/j
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bi therapy : aspirin/ clopidogrel Receives: Drug: Aspirin and Clopidogrel |
| 2 | Active comparator | Monotherapy: aspirin Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding
Measured: At each visit (every 6 months) with Follow-up of 3 years
Secondary outcomes (7)
Death
Measured: At each visit (every 6 months) with Follow-up of 3 years
Non fatal myocardial infarction
Measured: At each visit (every 6 months) with Follow-up of 3 years
Non fatal stroke
Measured: At each visit (every 6 months) with Follow-up of 3 years
Severe bleeding
Measured: At each visit (every 6 months) with Follow-up of 3 years
Stent thrombosis (ARC définition)
Measured: At each visit (every 6 months) with Follow-up of 3 years
Target lesion revascularization
Measured: At each visit (every 6 months) with Follow-up of 3 years
Moderate bleeding (ISTH definition)
Measured: At each visit (every 6 months) with Follow-up of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2014
- Study completionSep 2014
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Responsible party
- Sponsor
- Investigators
- Gérard HELFT, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822536
- Sponsor's protocol ID
- P071210
- Acronym
- OPTIDUAL
- Status last verified
- Oct 2014
- First submitted
- 13 Jan 2009
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E; OPTImal DUAL Antiplatelet Therapy Trial Investigators. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J. 2016 Jan 21;37(4):365-74. doi: 10.1093/eurheartj/ehv481. Epub 2015 Sep 12.
PubMed 26364288Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial. Trials. 2013 Feb 21;14:56. doi: 10.1186/1745-6215-14-56.
PubMed 23433461
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation
- ClinicalTrials.gov ID
- NCT00822536
- Acronym / sponsor ID
- OPTIDUAL / P071210
- Keywords
- Drug-eluting stent, Clopidogrel, Stent thrombosis, Myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,798 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Study start
- Jan 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jan 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.
To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.
Detailed description
Drug-eluting stents (DES) substantially reduce restenosis compared with bare metal stents and represent a significant advance in percutaneous coronary interventions (PCIs). Accordingly, DES have been rapidly adopted into practice and are currently used in the majority of PCI procedures. Despite their rapid acceptance, DES are not without limitations. In particular, patients who receive DES (like those who receive conventional bare metal stents) remain at risk of a 1% to 2% incidence of stent thrombosis, which is often associated with devastating consequences like death or myocardial infarction. Understanding and eliminating mediators of stent thrombosis are thus important goals for optimizing the clinical benefits of DES. Delayed endothelial coverage after DES implantation has been demonstrated and is thought to prolong the window of vulnerability to stent thrombosis. Consequently, current recommendations for DES are: dual antiplatelet therapy for at least 12 months in patients at low risk of bleeding, especially with " off-label " use. Because of rare but severe very late stent thrombosis, the dual antiplatelet therapy is more and more prescribed in clinical practice for several years.But it has been clearly demonstrated that the combination of aspirin and clopidogrel (the thienopyridine the most used) significantly increase the rate of severe and moderate bleedings when compared to aspirin alone. This is important if we consider the possibility or the necessity to prolong the combined antiplatelet therapy after stent implantation.ProposalTo compare treatment with aspirin alone versus the combined antiplatelet treatment with aspirin and clopidogrel after 12 months of combined antiplatelet treatment after DES implantation
NB : On the decision of the sponsor, the latest patient monitoring was advanced to September 30, 2014 instead of January 2015.
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 and ClopidogrelBi therapy : aspirin/ clopidogrel |
| 2 | Active comparator | Drug: AspirinMonotherapy: 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)
- Patients on aspirin and clopidogrel therapy at 12 months after DES implantation
- Informed, written consent by the patient
Key exclusion criteria (6 listed)
- DES in left main coronary artery
- Oral anticoagulation therapy with coumadin derivatives
- Active bleeding; bleeding diathesis; history intracranial bleeding
- Known allergy or intolerance to the study medications: aspirin and clopidogrel
- Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
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 |
|---|---|---|
| Aspirin and ClopidogrelAlso: Aspirin: acid acetylsalycilic, Clopidogrel: plavixAspirin <= 325 mg/j Clopidogrel = 75 mg /j | Drug | 1 |
| AspirinAlso: Aspirin: acid acetylsalycilicAspirin : <= 325 mg/j | Drug | 2 |
Primary outcome
Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding
Time frame: At each visit (every 6 months) with Follow-up of 3 years
7 secondary outcomes
Death
Time frame: At each visit (every 6 months) with Follow-up of 3 years
Non fatal myocardial infarction
Time frame: At each visit (every 6 months) with Follow-up of 3 years
Non fatal stroke
Time frame: At each visit (every 6 months) with Follow-up of 3 years
Severe bleeding
Time frame: At each visit (every 6 months) with Follow-up of 3 years
Stent thrombosis (ARC définition)
Time frame: At each visit (every 6 months) with Follow-up of 3 years
Target lesion revascularization
Time frame: At each visit (every 6 months) with Follow-up of 3 years
Moderate bleeding (ISTH definition)
Time frame: At each visit (every 6 months) with Follow-up of 3 years
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 17 Oct 2014.
- Derived from this study: PubMed 26364288Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E; OPTImal DUAL Antiplatelet Therapy Trial Investigators. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J. 2016 Jan 21;37(4):365-74. doi: 10.1093/eurheartj/ehv481. Epub 2015 Sep 12.
- Derived from this study: PubMed 23433461Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial. Trials. 2013 Feb 21;14:56. doi: 10.1186/1745-6215-14-56.
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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.
Gérard HELFT, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Clopidogrel and Aspirin in people with Coronary Artery Disease and Stent Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 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 17 Oct 2014. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding (time frame: At each visit (every 6 months) with Follow-up of 3 years). 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 NCT00822536, 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 17 Oct 2014.