Coronary Artery DiseasePhase 4ARCTICNCT00827411
Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and Interruption Versus Continuation of Double Antiplatelet Therapy
A Phase 4 study testing Aspirin and clopidogrel / Prasugrel, VerifyNow and Aspirin in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological monitoring reduces the rate of severe cardiovascular complications compared to a conventional strategy in patients scheduled for drug eluting stent implantation and followed up for one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Aspirin and clopidogrel / Prasugrel, VerifyNow and Aspirin
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jan 2013
- 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 (≥18 years) in whom elective DES stent placement is scheduled after diagnostic angiography
- Patients not treated by GPIIb/IIIa inhibitors prior to randomization.
- Provided written consent for participation in the trial prior to any study-specific procedures or requirements.
Who cannot join
- Oral anticoagulation (Vitamin K Antagonists).
- Contraindication for aspirin and/or clopidogrel/Prasugrel or GPIIb/IIIa inhibitors or to increasing dose of clopidogrel or aspirin
- Ongoing or recent bleeding and/or recent major surgery (<3 weeks)
- Severe liver dysfunction
- Thrombocytopenia (Platelet count <80000/µl).
- IIb/IIIa inhibitors within a week prior to randomization
Show all 11Show fewer
- STEMI presentation
- Patient at risk of poor compliance to the study
- Patient not affiliated to social security
- Pregnant women, no signed inform consent
- Any invasive or surgical planned intervention during the year after stent placement
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cardiologie- Hopital la Pitié Salpétrière
Paris, 75013
About this study
Official title: Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and a Interruption Versus Continuation of Double Antiplatelet Therapy, One Year After Stenting
Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological monitoring reduces the rate of severe cardiovascular complications compared to a conventional strategy in patients scheduled for drug eluting stent implantation and followed up for one year. Our second hypothesis is that interruption of clopidogrel / Prasugrel after one year of a combined therapy of clopidogrel/Prasugrel and aspirin is associated with a higher rate of severe cardiovascular complications as compared with patients in whom aspirin and clopidogrel / Prasugrel is maintained during the subsequent 6 months of follow-up.
Read the detailed description
Participating Centers : 38 french high PCI volume (>700) centers Rationale: Clopidogrel / Prasugrel (75 mg/day), in combination with aspirin (75 mg/day), is currently the antiplatelet treatment of choice for prevention of stent thrombosis, and clinical trials have shown that, in high-risk patients, prolonged dual antiplatelet treatment is more effective than aspirin alone in preventing major cardiovascular events. However, despite the use of clopidogrel, a considerable number of patients continue to have cardiovascular events. Numerous in VITRO studies have shown that individual responsiveness to clopidogrel but also to aspirin is not uniform in all patients and is subject to inter- and intraindividual variability. The recent possibility of bedside monitoring of oral antiplatelet therapy offers the unique opportunity of tailoring antiplatelet therapy. However, the relevance of such strategy has never been evaluated in a randomized prospective adequately powered study having long term follow-up (rationale 1). Late state stent thrombosis, especially in the era of drug eluting stent and after interruption of OAT, is another important safety issue raising the questions of the modalities of interruption of dual OAT after one year according to the most recent updated recommendations. Can we switch from dual to single OAT after one year? If so, what is the ischemic hazard? (Rational 2) Our first hypothesis is that a strategy of dose adjustment of OAT based on biological monitoring reduces the rate of the combined ischemic endpoints of death, urgent revascularization, stent thrombosis and stroke as compared to a conventional strategy (local practice without monitoring) in patients scheduled for DES implantation and followed up for one year. Our second hypothesis is that interruption of clopidogrel after one year of dual OAT is associated with a higher rate of the same combined ischemic endpoints as compared with patients in whom dual OAT is maintained during the subsequent 6 months of follow-up. Objectives: 1) To demonstrate the superiority of the strategy of monitoring with dose adjustment in suboptimal responders (Monitoring Arm) as compared to a more conventional strategy (Conventional Arm) with fixed dose regimen of both oral antiplatelet agents in all patients as defined by the international guidelines to reduce the primary endpoint evaluated one year after DES implantation. 2) to demonstrate the superiority of a strategy of pursuit of a dual OAT beyond one year (Pursuit Arm) as compared to a strategy of interruption (Interruption Arm).
Duration of the participation : from 18 up to 30 months according to the time delay from study start to randomization. No participants will be excluded from the study at the exception of consent withdrawal. However, participants who have not been randomized for interruption or continuation of DAPT at the 12 month follow up visit will terminate the study
Number of patients: 2500 patients. This number was obtained for the demonstration of the superiority of the strategy of monitoring (Monitoring Arm) over the conventional strategy (Conventional Arm) to reduce the primary endpoint by 33% (relative risk reduction).
Expected results: The ARCTIC study will provide answers to two major clinical challenges. It will also give a unique opportunity to assess the prevalence and the associated risk factors of suboptimal answers to OAT, but also to improve a suboptimal biological response. Finally, the economic impact of both strategies of monitoring and of interruption will be evaluated.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Aspirin and clopidogrel / Prasugrel, VerifyNow, Aspirin
- Keywords
- Drug Eluting Stent, Percutaneous coronary intervention, Oral antiplatelet therapy, Clopidogrel/Aspirin, Acute Coronary Syndrome
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin and clopidogrel / PrasugrelDrug
modification of aspirin and clopidogrel/Prasugrel maintenance doses based on a biological assay
VerifyNowDevice
point of care assay VerifyNow (ACCUMETRICS San Diego USA)
Aspirin and clopidogrel / PrasugrelDrug
aspirin and clopidogrel/ Prasugrel maintenance doses (according to international guidelines)
Aspirin and clopidogrel / PrasugrelDrug
maintenance dose of clopidogrel / Prasugrel and aspirin
AspirinDrug
Interruption of clopidogrel / Prasugrel after one year of follow-up
| Study group | Role | What they receive |
|---|---|---|
| 1: Monitoring Arm | Experimental | First randomization:
Monitoring Arm: dose adjustment of both aspirin and clopidogrel in suboptimal responders identified based on a point of care assay (VerifyNow). Receives: Drug: Aspirin and clopidogrel / Prasugrel; Device: VerifyNow |
| 2: Conventional Arm | Active comparator | First randomization:
Conventional Arm: fixed dose regiment of both aspirin and clopidogrel in all patients following DES implantation according to international guidelines Receives: Drug: Aspirin and clopidogrel / Prasugrel |
| 3: Pursuit Arm | Experimental | Second randomization after one year of follow-up:
Pursuit Arm: Pursuit of a dual oral antiplatelet therapy (aspirin and clopidogrel) beyond one year Receives: Drug: Aspirin and clopidogrel / Prasugrel |
| 4: Interruption Arm | Active comparator | Second randomization after one year of follow-up:
Interruption Arm: Interruption of clopidogrel therapy. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of death, myocardial infarction, stroke, urgent coronary revascularization, stent thrombosis assessed at one year for the first hypothesis and between 6 up to 18 months of follow-up for the second hypothesis
Measured: during the study (one year in both " monitoring " and " conventional " arms and during the periode from 6 up to 18 months in the "interruption" and "pursuit" arms)
Secondary outcomes (8)
Stent thrombosis and urgent coronary revascularization
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Rate of individual event at one year follow-up in both " monitoring " and " conventional " arms but also during the period from one year up to 24 months in the " interruption " and " pursuit " arms.
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Time delay from treatment interruption (randomization 2) to any thrombotic event (stent thrombosis, urgent revascularization, acute myocardial infarction, cardiac death) treatment interruption(randomisation 2)
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Treatment compliance evaluated by the number of oral antiplatelet treatment in both arms and with respect to all individual events of the primary composite endpoint
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Rate of use of GP IIb/IIIa receptor antagonists in both " monitoring " and " conventional " arms before percutaneous coronary intervention and in bail out situations and in both.
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Rate of suboptimal responders as defined by ARU>550 for aspirin or by a % of inhibition <15% and or a PRU<235) and the average dosage of aspirin and clopidogrel (in mg) will evaluated before and after dose adjustment (J0) and after each dose adjustment
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Net clinical benefit (death, myocardial infarction, urgent revascularization, stent thrombosis, stroke, major bleeding)
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Medico-economic evaluations will be performed for both hypotheses. The rate of rehospitalisation and the length of stay will be used as economic indicators
- at month 12 for the non-randomized patients at M12
- at month 12 and month 30 for the randomized patient
Measured: at month 12 and month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Allies in Cardiovascular Trials Initiatives and Organized, Institut National de la Santé Et de la Recherche Médicale, France, Sanofi, Bristol-Myers Squibb, Medtronic, Cordis US Corp., Fondation de France, Diagnostica Stago, Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Gilles Montalescot, PUPH, Principal investigator, Assistance Publique - Hôpitaux de ParisJean-Philippe Collet, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827411
- Sponsor's protocol ID
- P080403
- Acronym
- ARCTIC
- Status last verified
- Apr 2013
- First submitted
- 13 Jan 2009
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Collet JP, Cuisset T, Range G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.
PubMed 23121439Collet JP, Cayla G, Cuisset T, Elhadad S, Range G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J. 2011 Jan;161(1):5-12.e5. doi: 10.1016/j.ahj.2010.09.029.
PubMed 21167334Lattuca B, Silvain J, Yan Y, Pouillot C, Cuisset T, Cayla G, Henry P, Diallo A, Elhadad S, Range G, Lhermusier T, Boueri Z, Motreff P, Carrie D, Vicaut E, Montalescot G, Collet JP. Reasons for the Failure of Platelet Function Testing to Adjust Antiplatelet Therapy: Pharmacodynamic Insights From the ARCTIC Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007749. doi: 10.1161/CIRCINTERVENTIONS.118.007749. Epub 2019 Nov 7.
PubMed 31694410Collet JP, Hulot JS, Cuisset T, Range G, Cayla G, Van Belle E, Elhadad S, Rousseau H, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC investigators. Genetic and platelet function testing of antiplatelet therapy for percutaneous coronary intervention: the ARCTIC-GENE study. Eur J Clin Pharmacol. 2015 Nov;71(11):1315-24. doi: 10.1007/s00228-015-1917-9. Epub 2015 Aug 13.
PubMed 26265231Collet JP, Silvain J, Barthelemy O, Range G, Cayla G, Van Belle E, Cuisset T, Elhadad S, Schiele F, Lhoest N, Ohlmann P, Carrie D, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Montalescot G; ARCTIC investigators. Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial. Lancet. 2014 Nov 1;384(9954):1577-85. doi: 10.1016/S0140-6736(14)60612-7. Epub 2014 Jul 15.
PubMed 25037988Montalescot G, Range G, Silvain J, Bonnet JL, Boueri Z, Barthelemy O, Cayla G, Belle L, Van Belle E, Cuisset T, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Collet JP; ARCTIC Investigators. High on-treatment platelet reactivity as a risk factor for secondary prevention after coronary stent revascularization: A landmark analysis of the ARCTIC study. Circulation. 2014 May 27;129(21):2136-43. doi: 10.1161/CIRCULATIONAHA.113.007524. Epub 2014 Apr 9.
PubMed 24718568
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and a Interruption Versus Continuation of Double Antiplatelet Therapy, One Year After Stenting
- ClinicalTrials.gov ID
- NCT00827411
- Acronym / sponsor ID
- ARCTIC / P080403
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- Drug Eluting Stent, Percutaneous coronary intervention, Oral antiplatelet therapy, Clopidogrel/Aspirin, Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Allies in Cardiovascular Trials Initiatives and Organized, Institut National de la Santé Et de la Recherche Médicale, France, Sanofi, Bristol-Myers Squibb, Medtronic, Cordis US Corp., Fondation de France, Diagnostica Stago, Boston Scientific Corporation
- Study start
- Jan 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 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.
Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological monitoring reduces the rate of severe cardiovascular complications compared to a conventional strategy in patients scheduled for drug eluting stent implantation and followed up for one year. Our second hypothesis is that interruption of clopidogrel / Prasugrel after one year of a combined therapy of clopidogrel/Prasugrel and aspirin is associated with a higher rate of severe cardiovascular complications as compared with patients in whom aspirin and clopidogrel / Prasugrel is maintained during the subsequent 6 months of follow-up.
Detailed description
Participating Centers : 38 french high PCI volume (>700) centers Rationale: Clopidogrel / Prasugrel (75 mg/day), in combination with aspirin (75 mg/day), is currently the antiplatelet treatment of choice for prevention of stent thrombosis, and clinical trials have shown that, in high-risk patients, prolonged dual antiplatelet treatment is more effective than aspirin alone in preventing major cardiovascular events. However, despite the use of clopidogrel, a considerable number of patients continue to have cardiovascular events. Numerous in VITRO studies have shown that individual responsiveness to clopidogrel but also to aspirin is not uniform in all patients and is subject to inter- and intraindividual variability. The recent possibility of bedside monitoring of oral antiplatelet therapy offers the unique opportunity of tailoring antiplatelet therapy. However, the relevance of such strategy has never been evaluated in a randomized prospective adequately powered study having long term follow-up (rationale 1). Late state stent thrombosis, especially in the era of drug eluting stent and after interruption of OAT, is another important safety issue raising the questions of the modalities of interruption of dual OAT after one year according to the most recent updated recommendations. Can we switch from dual to single OAT after one year? If so, what is the ischemic hazard? (Rational 2) Our first hypothesis is that a strategy of dose adjustment of OAT based on biological monitoring reduces the rate of the combined ischemic endpoints of death, urgent revascularization, stent thrombosis and stroke as compared to a conventional strategy (local practice without monitoring) in patients scheduled for DES implantation and followed up for one year. Our second hypothesis is that interruption of clopidogrel after one year of dual OAT is associated with a higher rate of the same combined ischemic endpoints as compared with patients in whom dual OAT is maintained during the subsequent 6 months of follow-up. Objectives: 1) To demonstrate the superiority of the strategy of monitoring with dose adjustment in suboptimal responders (Monitoring Arm) as compared to a more conventional strategy (Conventional Arm) with fixed dose regimen of both oral antiplatelet agents in all patients as defined by the international guidelines to reduce the primary endpoint evaluated one year after DES implantation. 2) to demonstrate the superiority of a strategy of pursuit of a dual OAT beyond one year (Pursuit Arm) as compared to a strategy of interruption (Interruption Arm).
Duration of the participation : from 18 up to 30 months according to the time delay from study start to randomization. No participants will be excluded from the study at the exception of consent withdrawal. However, participants who have not been randomized for interruption or continuation of DAPT at the 12 month follow up visit will terminate the study
Number of patients: 2500 patients. This number was obtained for the demonstration of the superiority of the strategy of monitoring (Monitoring Arm) over the conventional strategy (Conventional Arm) to reduce the primary endpoint by 33% (relative risk reduction).
Expected results: The ARCTIC study will provide answers to two major clinical challenges. It will also give a unique opportunity to assess the prevalence and the associated risk factors of suboptimal answers to OAT, but also to improve a suboptimal biological response. Finally, the economic impact of both strategies of monitoring and of interruption will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Monitoring Arm | Experimental | Drug: Aspirin and clopidogrel / Prasugrel, Device: VerifyNowFirst randomization: Monitoring Arm: dose adjustment of both aspirin and clopidogrel in suboptimal responders identified based on a point of care assay (VerifyNow). |
| 2: Conventional Arm | Active comparator | Drug: Aspirin and clopidogrel / PrasugrelFirst randomization: Conventional Arm: fixed dose regiment of both aspirin and clopidogrel in all patients following DES implantation according to international guidelines |
| 3: Pursuit Arm | Experimental | Drug: Aspirin and clopidogrel / PrasugrelSecond randomization after one year of follow-up: Pursuit Arm: Pursuit of a dual oral antiplatelet therapy (aspirin and clopidogrel) beyond one year |
| 4: Interruption Arm | Active comparator | Drug: AspirinSecond randomization after one year of follow-up: Interruption Arm: Interruption of clopidogrel therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (≥18 years) in whom elective DES stent placement is scheduled after diagnostic angiography
- Patients not treated by GPIIb/IIIa inhibitors prior to randomization.
- Provided written consent for participation in the trial prior to any study-specific procedures or requirements.
Key exclusion criteria (11 listed)
- Oral anticoagulation (Vitamin K Antagonists).
- Contraindication for aspirin and/or clopidogrel/Prasugrel or GPIIb/IIIa inhibitors or to increasing dose of clopidogrel or aspirin
- Ongoing or recent bleeding and/or recent major surgery (<3 weeks)
- Severe liver dysfunction
- Thrombocytopenia (Platelet count <80000/µl).
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 clopidogrel / Prasugrelmodification of aspirin and clopidogrel/Prasugrel maintenance doses based on a biological assay | Drug | 1: Monitoring Arm |
| VerifyNowpoint of care assay VerifyNow (ACCUMETRICS San Diego USA) | Device | 1: Monitoring Arm |
| Aspirin and clopidogrel / Prasugrelaspirin and clopidogrel/ Prasugrel maintenance doses (according to international guidelines) | Drug | 2: Conventional Arm |
| Aspirin and clopidogrel / Prasugrelmaintenance dose of clopidogrel / Prasugrel and aspirin | Drug | 3: Pursuit Arm |
| AspirinInterruption of clopidogrel / Prasugrel after one year of follow-up | Drug | 4: Interruption Arm |
Primary outcome
Composite endpoint of death, myocardial infarction, stroke, urgent coronary revascularization, stent thrombosis assessed at one year for the first hypothesis and between 6 up to 18 months of follow-up for the second hypothesis
Time frame: during the study (one year in both " monitoring " and " conventional " arms and during the periode from 6 up to 18 months in the "interruption" and "pursuit" arms)
8 secondary outcomes
Stent thrombosis and urgent coronary revascularization
Time frame: at month 12 and month 30
Rate of individual event at one year follow-up in both " monitoring " and " conventional " arms but also during the period from one year up to 24 months in the " interruption " and " pursuit " arms.
Time frame: at month 12 and month 30
Time delay from treatment interruption (randomization 2) to any thrombotic event (stent thrombosis, urgent revascularization, acute myocardial infarction, cardiac death) treatment interruption(randomisation 2)
Time frame: at month 12 and month 30
Treatment compliance evaluated by the number of oral antiplatelet treatment in both arms and with respect to all individual events of the primary composite endpoint
Time frame: at month 12 and month 30
Rate of use of GP IIb/IIIa receptor antagonists in both " monitoring " and " conventional " arms before percutaneous coronary intervention and in bail out situations and in both.
Time frame: at month 12 and month 30
Rate of suboptimal responders as defined by ARU>550 for aspirin or by a % of inhibition <15% and or a PRU<235) and the average dosage of aspirin and clopidogrel (in mg) will evaluated before and after dose adjustment (J0) and after each dose adjustment
Time frame: at month 12 and month 30
Net clinical benefit (death, myocardial infarction, urgent revascularization, stent thrombosis, stroke, major bleeding)
Time frame: at month 12 and month 30
Medico-economic evaluations will be performed for both hypotheses. The rate of rehospitalisation and the length of stay will be used as economic indicators
Time frame: at month 12 and month 30
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 Apr 2013.
- Results publication: PubMed 23121439Collet JP, Cuisset T, Range G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.
- Results publication: PubMed 21167334Collet JP, Cayla G, Cuisset T, Elhadad S, Range G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J. 2011 Jan;161(1):5-12.e5. doi: 10.1016/j.ahj.2010.09.029.
- Derived from this study: PubMed 31694410Lattuca B, Silvain J, Yan Y, Pouillot C, Cuisset T, Cayla G, Henry P, Diallo A, Elhadad S, Range G, Lhermusier T, Boueri Z, Motreff P, Carrie D, Vicaut E, Montalescot G, Collet JP. Reasons for the Failure of Platelet Function Testing to Adjust Antiplatelet Therapy: Pharmacodynamic Insights From the ARCTIC Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007749. doi: 10.1161/CIRCINTERVENTIONS.118.007749. Epub 2019 Nov 7.
- Derived from this study: PubMed 26265231Collet JP, Hulot JS, Cuisset T, Range G, Cayla G, Van Belle E, Elhadad S, Rousseau H, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC investigators. Genetic and platelet function testing of antiplatelet therapy for percutaneous coronary intervention: the ARCTIC-GENE study. Eur J Clin Pharmacol. 2015 Nov;71(11):1315-24. doi: 10.1007/s00228-015-1917-9. Epub 2015 Aug 13.
- Derived from this study: PubMed 25037988Collet JP, Silvain J, Barthelemy O, Range G, Cayla G, Van Belle E, Cuisset T, Elhadad S, Schiele F, Lhoest N, Ohlmann P, Carrie D, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Montalescot G; ARCTIC investigators. Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial. Lancet. 2014 Nov 1;384(9954):1577-85. doi: 10.1016/S0140-6736(14)60612-7. Epub 2014 Jul 15.
- Derived from this study: PubMed 24718568Montalescot G, Range G, Silvain J, Bonnet JL, Boueri Z, Barthelemy O, Cayla G, Belle L, Van Belle E, Cuisset T, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Collet JP; ARCTIC Investigators. High on-treatment platelet reactivity as a risk factor for secondary prevention after coronary stent revascularization: A landmark analysis of the ARCTIC study. Circulation. 2014 May 27;129(21):2136-43. doi: 10.1161/CIRCULATIONAHA.113.007524. Epub 2014 Apr 9.
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Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Gilles Montalescot, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
Jean-Philippe Collet, PH 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 / Prasugrel, VerifyNow and Aspirin in people with Coronary Artery Disease and Acute Coronary Syndrome, 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 3 inclusion and 11 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 Apr 2013. 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 endpoint of death, myocardial infarction, stroke, urgent coronary revascularization, stent thrombosis assessed at one year for the first hypothesis and between 6 up to 18 months of follow-up for the second hypothesis (time frame: during the study (one year in both " monitoring " and " conventional " arms and during the periode from 6 up to 18 months in the "interruption" and "pursuit" arms)). 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 NCT00827411, which also lists 6 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 12 Apr 2013.