Acute Coronary SyndromePhase 4ANTARCTICNCT01538446
Tailored Antiplatelet Therapy Versus Recommended Dose of Prasugrel
A Phase 4 study testing Modification of Prasugrel based on a biological assay, prasugrel / clopidogrel and Verify Now in people with Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The purpose of this study is to demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Modification of Prasugrel based on a biological assay, prasugrel / clopidogrel and Verify Now
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2012to May 2016
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acute coronary syndrome (STEMI and NSTEMI) treated by PCI
- Stent (bare metal stent or drug eluting stent) regardless of the regime of thienopyridines administered before randomisation
- Age ≥ 75 years.
- Aspirin dose of 75 mg will be recommended but study authorizes doses ranging from 75-160 mg
- Ability to understand and to comply with the study protocol.
- Written informed consent
Who cannot join
- Prior history of ischemic or hemorrhagic stroke or transient ischemic attack, or sub-arachnoids haemorrhage
- Have received fibrinolytic therapy within 48 hours of entry or randomisation into the study
- Are receiving vitamin K antagonist
- Concomitant medical illness (terminal malignancy) that is associated with reduced survival over the expected study treatment period.
- History of intolerance or allergy to ASA or approved thienopyridines (ticlopidine, clopidogrel, or prasugrel)
- Have active pathological bleeding or history of bleeding diathesis
Show all 9Show fewer
- Thrombocytopenia < 100 000 µL
- Severe hepatic impairment (Child Pugh class C).
- Have a condition associated with poor treatment compliance, including dementia or mental illness
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Caremeau à Nimes - Service de Cardiologie
Nîmes, 30029
ACTION study group - Institut de Cardiologie- Hôpital la Pitié Salpêtrière
Paris, 75013
About this study
Official title: The ANTARCTIC Study - Assessment of a Normal Versus Tailored Dose of Prasugrel After Stenting in Patients Aged > 75 Years to Reduce the Composite of Bleeding, Stent Thrombosis and Ischemic Complications
The purpose of this study is to demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every patient without monitoring (Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular (CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type "definite"), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).
Read the detailed description
Objective: To demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every patient without monitoring (Conventional Arm).Rationale: Prasugrel 10 mg is superior to clopidogrel in patients with acute coronary syndrome treated by percutaneous coronary intervention, reducing significantly the rates of ischemic events. Elderly patients appear to be at higher risk of bleeding events and pharmacokinetic data suggests that elderly patients are exposed to a higher concentration of the active metabolite of prasugrel. A reduced dose of 5 mg of prasugrel is therefore proposed to these patients to limit the risk of bleeding. On the other hand, the elderly have also a higher ischemic risk and higher levels of platelet aggregation under treatment than younger patients and may deserve stronger protection from antiplatelet therapy. Platelet function testing appears to be of particular interest in patients at high risk of both ischemic and bleeding events like the elderly. Too intense platelet inhibition may expose the elderly patients to an excessive bleeding risk. Too low platelet inhibition may expose them to recurrent cardiovascular ischemic events. The possibility of bedside monitoring of oral antiplatelet therapy offers the opportunity of tailoring prasugrel therapy in elderly patients to optimize their risk/benefit ratio. Such strategy has never been evaluated in a randomized and adequately powered study. Population: Acute coronary syndrome (STEMI and NSTEMI) treated by PCI-stent (bare metal stent or drug eluting stent) in patients aged 75 ≥ year. Methods: Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR). Patients will be monitored again 2 weeks later, only if they do not meet the Verifynow P2Y12 targets at the first assessment. Primary endpoint net clinical benefit at 12 months:Composite of Cardiovascular death, myocardial infarction, stroke, urgent revascularisation, stent thrombosis and bleedings according to the BARC definitions (type 2, 3 or 5) Centers: Approximately 40 French high volume PCI centers
- Conditions
- Acute Coronary Syndrome
- Being tested
- Modification of Prasugrel based on a biological assay, prasugrel / clopidogrel, Verify Now
- Keywords
- Elderly, Acute coronary syndrome, Percutaneous coronary intervention, Prasugrel, Platelet function test
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modification of Prasugrel based on a biological assayDrug
Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA)
prasugrel / clopidogrelDrug
fixed dose of prasugrel 5 mg
Verify NowDevice
Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA)
| Study group | Role | What they receive |
|---|---|---|
| 1: Monitoring Arm | Experimental | Monitoring Arm: dose adjustment of prasugrel with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders Receives: Drug: Modification of Prasugrel based on a biological assay; Device: Verify Now |
| 2: Conventional Arm | Active comparator | Conventional Arm: fixed dose of prasugrel 5 mg Receives: Drug: prasugrel / clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Cardiovascular death, myocardial infarction, stroke, urgent revascularisation, stent thrombosis and bleedings according to the BARC definitions (type 2, 3 or 5) through 12 months of randomisation
Composite of Cardiovascular death, myocardial infarction, stroke, urgent revascularisation, stent thrombosis and bleedings according to the BARC definitions (type 2, 3 or 5) through 12 months of randomisation
Measured: through 12 months of randomisation
Secondary outcomes (16)
Evaluation of the benefice of prasugrel adjustment on the composite ischemic endpoint of cardiovascular (CV) death, MI, definite stent thrombosis and Urgent revascularisation through 12 months of randomisation
The key secondary objective is to evaluate the benefice of prasugrel adjustment on the composite ischemic endpoint of cardiovascular (CV) death, MI, definite stent thrombosis and Urgent revascularisation through 12 months of randomisation
Measured: through 12 months of randomisation
CV death, MI, stroke through 12 months of randomisation
Measured: through 12 months of randomisation
CV death, MI, stroke or Urgent Revascularization through 12 months of randomisation
Measured: through 12 months of randomisation
CV death: any death
Measured: 12 months after randomization
Any death or resuscitated cardiac death
Measured: 12 months after randomization
CV death or MI
Measured: 12 months after randomization
Definite stent thrombosis (ARC definition)
Measured: 12 months after randomization
All types of bleeding according to the BARC definitions 1, 2, 3, 4, 5
Measured: 12 months after randomization
BARC Bleeding of type 2, 3 or 5
Measured: 12 months after randomization
Bleeding TIMI major through 12 months of randomisation
Measured: through 12 months of randomisation
GUSTO severe or moderate bleeding
Measured: 12 months after randomization
STEEPLE bleeding definitions (major, minor or both)
Measured: 12 months after randomization
ISTH bleeding definitions (major and clinically relevant non major)
Measured: 12 months after randomization
Bleeding TIMI minor
Measured: 12 months after randomization
Bleeding TIMI minimal
Measured: 12 months after randomization
Bleeding TIMI major, minor and combination
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Daiichi Sankyo, Allies in Cardiovascular Trials Initiatives and Organized, Accumetrics, Inc., Stentys
- Responsible party
- Sponsor
- Investigators
- Gilles MONTALESCOT, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538446
- Sponsor's protocol ID
- P110101
- Acronym
- ANTARCTIC
- Status last verified
- Jan 2017
- First submitted
- 20 Feb 2012
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cayla G, Cuisset T, Silvain J, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, Bellemain-Appaix A, Range G, El Mahmoud R, Carrie D, Belle L, Souteyrand G, Aubry P, Sabouret P, du Fretay XH, Beygui F, Bonnet JL, Lattuca B, Pouillot C, Varenne O, Boueri Z, Van Belle E, Henry P, Motreff P, Elhadad S, Salem JE, Abtan J, Rousseau H, Collet JP, Vicaut E, Montalescot G; ANTARCTIC investigators. Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial. Lancet. 2016 Oct 22;388(10055):2015-2022. doi: 10.1016/S0140-6736(16)31323-X. Epub 2016 Aug 28.
PubMed 27581531Lattuca B, Cayla G, Silvain J, Cuisset T, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, El Mahmoud R, Carrie D, Souteyrand G, Kerneis M, Hauguel-Moreau M, Zeitouni M, Guedeney P, Diallo A, Collet JP, Vicaut E, Montalescot G; ACTION Study Group. Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial. Am J Cardiovasc Drugs. 2021 Nov;21(6):681-691. doi: 10.1007/s40256-021-00468-8. Epub 2021 Jun 30.
PubMed 34191259Cayla G, Cuisset T, Silvain J, Henry P, Leclercq F, Carrie D, Etienne CS, Belle L, Range G, Pouillot C, Varenne O, Van Belle E, Boueri Z, Motreff P, Elhadad S, Delarche N, El Mahmoud R, Vicaut E, Collet JP, Montalescot G; ANTARCTIC investigators. Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: design of the randomized antarctic study. Am Heart J. 2014 Nov;168(5):674-81. doi: 10.1016/j.ahj.2014.07.026. Epub 2014 Aug 7.
PubMed 25440795
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ANTARCTIC Study - Assessment of a Normal Versus Tailored Dose of Prasugrel After Stenting in Patients Aged > 75 Years to Reduce the Composite of Bleeding, Stent Thrombosis and Ischemic Complications
- ClinicalTrials.gov ID
- NCT01538446
- Acronym / sponsor ID
- ANTARCTIC / P110101
- Conditions
- Acute Coronary Syndrome
- Keywords
- Elderly, Acute coronary syndrome, Percutaneous coronary intervention, Prasugrel, Platelet function test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Daiichi Sankyo, Allies in Cardiovascular Trials Initiatives and Organized, Accumetrics, Inc., Stentys
- Study start
- Mar 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Feb 2012 (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 this study is to demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every patient without monitoring (Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular (CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type "definite"), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).
Detailed description
Objective: To demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every patient without monitoring (Conventional Arm).Rationale: Prasugrel 10 mg is superior to clopidogrel in patients with acute coronary syndrome treated by percutaneous coronary intervention, reducing significantly the rates of ischemic events. Elderly patients appear to be at higher risk of bleeding events and pharmacokinetic data suggests that elderly patients are exposed to a higher concentration of the active metabolite of prasugrel. A reduced dose of 5 mg of prasugrel is therefore proposed to these patients to limit the risk of bleeding. On the other hand, the elderly have also a higher ischemic risk and higher levels of platelet aggregation under treatment than younger patients and may deserve stronger protection from antiplatelet therapy. Platelet function testing appears to be of particular interest in patients at high risk of both ischemic and bleeding events like the elderly. Too intense platelet inhibition may expose the elderly patients to an excessive bleeding risk. Too low platelet inhibition may expose them to recurrent cardiovascular ischemic events. The possibility of bedside monitoring of oral antiplatelet therapy offers the opportunity of tailoring prasugrel therapy in elderly patients to optimize their risk/benefit ratio. Such strategy has never been evaluated in a randomized and adequately powered study. Population: Acute coronary syndrome (STEMI and NSTEMI) treated by PCI-stent (bare metal stent or drug eluting stent) in patients aged 75 ≥ year. Methods: Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR). Patients will be monitored again 2 weeks later, only if they do not meet the Verifynow P2Y12 targets at the first assessment. Primary endpoint net clinical benefit at 12 months:Composite of Cardiovascular death, myocardial infarction, stroke, urgent revascularisation, stent thrombosis and bleedings according to the BARC definitions (type 2, 3 or 5) Centers: Approximately 40 French high volume PCI centers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Monitoring Arm | Experimental | Drug: Modification of Prasugrel based on a biological assay, Device: Verify NowMonitoring Arm: dose adjustment of prasugrel with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders |
| 2: Conventional Arm | Active comparator | Drug: prasugrel / clopidogrelConventional Arm: fixed dose of prasugrel 5 mg |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Acute coronary syndrome (STEMI and NSTEMI) treated by PCI
- Stent (bare metal stent or drug eluting stent) regardless of the regime of thienopyridines administered before randomisation
- Age ≥ 75 years.
- Aspirin dose of 75 mg will be recommended but study authorizes doses ranging from 75-160 mg
- Ability to understand and to comply with the study protocol.
Key exclusion criteria (9 listed)
- Prior history of ischemic or hemorrhagic stroke or transient ischemic attack, or sub-arachnoids haemorrhage
- Have received fibrinolytic therapy within 48 hours of entry or randomisation into the study
- Are receiving vitamin K antagonist
- Concomitant medical illness (terminal malignancy) that is associated with reduced survival over the expected study treatment period.
- History of intolerance or allergy to ASA or approved thienopyridines (ticlopidine, clopidogrel, or prasugrel)
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 |
|---|---|---|
| Modification of Prasugrel based on a biological assayMonitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA) | Drug | 1: Monitoring Arm |
| prasugrel / clopidogrelfixed dose of prasugrel 5 mg | Drug | 2: Conventional Arm |
| Verify NowMonitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA) | Device | 1: Monitoring Arm |
Primary outcome
Composite of Cardiovascular death, myocardial infarction, stroke, urgent revascularisation, stent thrombosis and bleedings according to the BARC definitions (type 2, 3 or 5) through 12 months of randomisation
Time frame: through 12 months of randomisation
Composite of Cardiovascular death, myocardial infarction, stroke, urgent revascularisation, stent thrombosis and bleedings according to the BARC definitions (type 2, 3 or 5) through 12 months of randomisation
16 secondary outcomes
Evaluation of the benefice of prasugrel adjustment on the composite ischemic endpoint of cardiovascular (CV) death, MI, definite stent thrombosis and Urgent revascularisation through 12 months of randomisation
Time frame: through 12 months of randomisation
CV death, MI, stroke through 12 months of randomisation
Time frame: through 12 months of randomisation
CV death, MI, stroke or Urgent Revascularization through 12 months of randomisation
Time frame: through 12 months of randomisation
CV death: any death
Time frame: 12 months after randomization
Any death or resuscitated cardiac death
Time frame: 12 months after randomization
CV death or MI
Time frame: 12 months after randomization
Definite stent thrombosis (ARC definition)
Time frame: 12 months after randomization
All types of bleeding according to the BARC definitions 1, 2, 3, 4, 5
Time frame: 12 months after randomization
BARC Bleeding of type 2, 3 or 5
Time frame: 12 months after randomization
Bleeding TIMI major through 12 months of randomisation
Time frame: through 12 months of randomisation
GUSTO severe or moderate bleeding
Time frame: 12 months after randomization
STEEPLE bleeding definitions (major, minor or both)
Time frame: 12 months after randomization
ISTH bleeding definitions (major and clinically relevant non major)
Time frame: 12 months after randomization
Bleeding TIMI minor
Time frame: 12 months after randomization
Bleeding TIMI minimal
Time frame: 12 months after randomization
Bleeding TIMI major, minor and combination
Time frame: 12 months after randomization
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 11 Jan 2017.
- Results publication: PubMed 27581531Cayla G, Cuisset T, Silvain J, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, Bellemain-Appaix A, Range G, El Mahmoud R, Carrie D, Belle L, Souteyrand G, Aubry P, Sabouret P, du Fretay XH, Beygui F, Bonnet JL, Lattuca B, Pouillot C, Varenne O, Boueri Z, Van Belle E, Henry P, Motreff P, Elhadad S, Salem JE, Abtan J, Rousseau H, Collet JP, Vicaut E, Montalescot G; ANTARCTIC investigators. Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial. Lancet. 2016 Oct 22;388(10055):2015-2022. doi: 10.1016/S0140-6736(16)31323-X. Epub 2016 Aug 28.
- Derived from this study: PubMed 34191259Lattuca B, Cayla G, Silvain J, Cuisset T, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, El Mahmoud R, Carrie D, Souteyrand G, Kerneis M, Hauguel-Moreau M, Zeitouni M, Guedeney P, Diallo A, Collet JP, Vicaut E, Montalescot G; ACTION Study Group. Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial. Am J Cardiovasc Drugs. 2021 Nov;21(6):681-691. doi: 10.1007/s40256-021-00468-8. Epub 2021 Jun 30.
- Derived from this study: PubMed 25440795Cayla G, Cuisset T, Silvain J, Henry P, Leclercq F, Carrie D, Etienne CS, Belle L, Range G, Pouillot C, Varenne O, Van Belle E, Boueri Z, Motreff P, Elhadad S, Delarche N, El Mahmoud R, Vicaut E, Collet JP, Montalescot G; ANTARCTIC investigators. Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: design of the randomized antarctic study. Am Heart J. 2014 Nov;168(5):674-81. doi: 10.1016/j.ahj.2014.07.026. Epub 2014 Aug 7.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery 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, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Modification of Prasugrel based on a biological assay, prasugrel / clopidogrel and Verify Now in people with Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 6 inclusion and 9 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 of Cardiovascular death, myocardial infarction, stroke, urgent revascularisation, stent thrombosis and bleedings according to the BARC definitions (type 2, 3 or 5) through 12 months of randomisation (time frame: through 12 months of randomisation). 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 NCT01538446, which also lists 3 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 11 Jan 2017.