Monotherapy After PCIASETNCT03469856
Acetyl Salicylic Elimination Trial: The ASET Pilot Study
A study testing Prasugrel monotherapy in people with Monotherapy After PCI, run by Pedro A. Lemos at 1 site in Brazil.
Trial summary
A multicenter, single arm, open-label trial of prasugrel monotherapy after PCI with the new-generation thin-strut biodegradable polymer everolimus-eluting SYNERGY® stent in patients with chronic stable angina Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Monotherapy After PCI
- What is being tested?
- Prasugrel monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Feb 2018to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Successful PCI with optimal acute stent implantation results (based on local standard of care by angiography and/or findings from intracoronary imaging and on investigators' discretion) of one or more everolimus-eluting SYNERGY® stent(s). Typically, optimal acute coronary stenting result is a combination of successful stent implantation at the target lesion with absence of significant residual diameter stenosis (<20%), no edge dissection, no thrombus, no major side branch occlusion, "no-reflow", no major stent under-expansion or major stent incomplete apposition.
- 2. Everolimus-eluting SYNERGY® stent implantation was performed to treat:
- patients with at least one stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in at least one major epicardial territory (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) with a vessel size between 2.25 mm and 4.0 mm in diameter supplying viable myocardium without left main stem involvement;
- Non-acute coronary disease, with normal cardiac troponin values prior to the PCI procedure, and evidences of myocardial ischemia by symptoms or non-invasive testing (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography);
- patients anatomical SYNTAX Score < 23 prior to everolimus-eluting SYNERGY® stent implantation; 3. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site;
Who cannot join
- Candidates will be ineligible for enrolment in the study if any of the following conditions apply:
- Under the age of 18 years or ≥ 75 years;
- Patients weighing < 60 kg;
- Unable to give Informed Consent;
- Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication.
- Female who is breastfeeding at time of enrolment;
Show all 14Show fewer
- Previous PCI in the last 12 months;
- Current (same hospitalization) or previous (within 12 months) acute coronary syndrome
- Patient with following lesion characteristics prior to everolimus-eluting SYNERGY® stent implantation:
- Left-main disease
- Chronic Total Occlusion
- Bifurcation lesion requiring two stent treatment
- Saphenous or arterial graft
- Severe calcification necessitating the use of rotablator 9. Patients with any previous history of definite stent thrombosis. 10. Patients treated with everolimus-eluting SYNERGY® stent(s) but who also concomitantly received any other non-study stent at the same procedure (all lesions must be treated with everolimus-eluting SYNERGY® stent); 11. Patients with planned PCI or surgical intervention to treat any cardiac or non-cardiac condition within the next 6 months; 12. Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement); 13. Atrial fibrillation or other indication for oral anticoagulant therapy; 14. Known allergy to aspirin, prasugrel or diagnosed lactose intolerance; 15. Glomerular filtration rate below 60mL/min; 16. Previous stroke or transient ischemic cerebrovascular accident (TIA); 17. Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk; 18. Haemoglobin <10 g/dL or other evidence of active bleeding; 19. Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy; 20. Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with prasugrel; 21. Participation in another trial with an investigational drug or device; 22. Co-morbidity associated with life expectancy less than 1 year; 23. Assessment that the subject is not likely to comply with the study procedures or have complete follow-up; 24. Known drug or alcohol dependence within the past 12 months as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute - InCor
São Paulo, São Paulo, 05403-000
Expedito Ribeiro, MD PhD, +55 11 2661 5614, expribeiro@incor.usp.br
Patricia Pereira, RN, +55 11 26624030, patricia.pereira@incor.usp.br
About this study
Official title: ASET Clinical Investigational Plan Acetyl Salicylic Elimination Trial: The ASET Pilot Study
A multicenter, single arm, open-label trial of prasugrel monotherapy after PCI with the new-generation thin-strut biodegradable polymer everolimus-eluting SYNERGY® stent in patients with chronic stable angina
Read the detailed description
Single antiplatelet therapy with prasugrel is safe in selected patients undergoing successful PCI with the new generation biodegradable polymer everolimus-eluting SYNERGY® stent.
To assess in a proof-of-concept study the safety of single antiplatelet therapy with prasugrel after PCI with a new generation biodegradable polymer drug eluting stent in terms of ischemic and bleeding outcomes.
The ASET Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal PCI for chronic stable angina with normal cardiac biomarkers values. The patients will be loaded with standard dual antiplatelet therapy according to local practice (usually aspirin 300 mg and clopidogrel 600 mg, unless patient is on long-term therapy) at least 2 hours prior to the diagnostic catheterization or PCI procedure. After PCI, if the results are considered to be satisfactory by the operator based on clinical (e.g. clinical status, ECG, etc.), angiographic and/or findings from intracoronary imaging, only then patients will be enrolled in the study and loaded with prasugrel 60 mg and continued with prasugrel only (10 mg once a day) for three months. Aspirin and clopidogrel will be discontinued. At the 3-months follow-up visit, prasugrel (only) will be replaced by aspirin (only) or dual-antiplatelet therapy according to local standard of care. Clinical follow-up with office visit will be performed at 3 months and telephone contacts at 1, and 4 months (final follow-up). All events will be adjudicated by an independent clinical events committee (CEC).
An independent Data Safety and Monitoring Board (DSMB) will monitor the individual and collective safety of the patients in the study during enrolment phase and up to 3 months follow-up (primary endpoint).
The ASET study is a proof-of-concept pilot, feasibility and safety study designed as a single arm, open label trial with a stopping rule based on the occurrence of definite stent thrombosis. Based on previous pilot studies, 200 patients will be enrolled. The trial will be terminated if more than three (>3) patients experience definite stent thrombosis following index procedure till 4 months follow-up.
- Conditions
- Monotherapy After PCI
- Being tested
- Prasugrel monotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasugrel monotherapyDrug
Also called PCI with the SYNERGY® stent
A multicenter, single arm, open-label trial of in patients with chronic stable angina
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | The ASET Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal PCI for chronic stable angina with normal cardiac biomarkers values. angiographic and/or findings from intracoronary imaging, only then patients will be enrolled in the study and loaded with prasugrel 60 mg and continued with prasugrel only (10 mg once a day) for three months. Aspirin and clopidogrel will be discontinued. At the 3-months follow-up visit, prasugrel (only) will be replaced by aspirin (only) or dual-antiplatelet therapy according to local standard of care. Receives: Drug: Prasugrel monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Ischemic Endpoint
Composite of cardiac death, target-vessel myocardial infarction (spontaneous >48 hours) orn definite stent thrombosis
Measured: 3 months
Primary Bleeding Endpoint
BARC 3 - 5 bleeding
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start22 Feb 2018
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monotherapy After PCIStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The ASET Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal PCI for chronic stable angina with normal cardiac biomarkers values.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedro A. Lemos
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Cardialysis B.V.
- Responsible party
- Sponsor-investigator, Pedro A. Lemos, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469856
- Sponsor's protocol ID
- DSC 4579/17/079
- Acronym
- ASET
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kogame N, Guimaraes PO, Modolo R, De Martino F, Tinoco J, Ribeiro EE, Kawashima H, Ono M, Hara H, Wang R, Cavalcante R, Moulin B, Falcao BAA, Leite RS, de Almeida Sampaio FB, Morais GR, Meireles GC, Campos CM, Onuma Y, Serruys PW, Lemos PA. Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study. JACC Cardiovasc Interv. 2020 Oct 12;13(19):2251-2262. doi: 10.1016/j.jcin.2020.06.023. Epub 2020 Sep 16.
PubMed 32950419
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASET Clinical Investigational Plan Acetyl Salicylic Elimination Trial: The ASET Pilot Study
- ClinicalTrials.gov ID
- NCT03469856
- Acronym / sponsor ID
- ASET / DSC 4579/17/079
- Conditions
- Monotherapy After PCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pedro A. LemosUniversity, hospital or other
- Collaborators
- Imperial College London, Cardialysis B.V.
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 19 Mar 2018 (actual)
- 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.
A multicenter, single arm, open-label trial of prasugrel monotherapy after PCI with the new-generation thin-strut biodegradable polymer everolimus-eluting SYNERGY® stent in patients with chronic stable angina
Detailed description
Single antiplatelet therapy with prasugrel is safe in selected patients undergoing successful PCI with the new generation biodegradable polymer everolimus-eluting SYNERGY® stent.
To assess in a proof-of-concept study the safety of single antiplatelet therapy with prasugrel after PCI with a new generation biodegradable polymer drug eluting stent in terms of ischemic and bleeding outcomes.
The ASET Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal PCI for chronic stable angina with normal cardiac biomarkers values. The patients will be loaded with standard dual antiplatelet therapy according to local practice (usually aspirin 300 mg and clopidogrel 600 mg, unless patient is on long-term therapy) at least 2 hours prior to the diagnostic catheterization or PCI procedure. After PCI, if the results are considered to be satisfactory by the operator based on clinical (e.g. clinical status, ECG, etc.), angiographic and/or findings from intracoronary imaging, only then patients will be enrolled in the study and loaded with prasugrel 60 mg and continued with prasugrel only (10 mg once a day) for three months. Aspirin and clopidogrel will be discontinued. At the 3-months follow-up visit, prasugrel (only) will be replaced by aspirin (only) or dual-antiplatelet therapy according to local standard of care. Clinical follow-up with office visit will be performed at 3 months and telephone contacts at 1, and 4 months (final follow-up). All events will be adjudicated by an independent clinical events committee (CEC).
An independent Data Safety and Monitoring Board (DSMB) will monitor the individual and collective safety of the patients in the study during enrolment phase and up to 3 months follow-up (primary endpoint).
The ASET study is a proof-of-concept pilot, feasibility and safety study designed as a single arm, open label trial with a stopping rule based on the occurrence of definite stent thrombosis. Based on previous pilot studies, 200 patients will be enrolled. The trial will be terminated if more than three (>3) patients experience definite stent thrombosis following index procedure till 4 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The ASET Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal PCI for chronic stable angina with normal cardiac biomarkers values.
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Drug: Prasugrel monotherapyThe ASET Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal PCI for chronic stable angina with normal cardiac biomarkers values. angiographic and/or findings from intracoronary imaging, only then patients will be enrolled in the study and loaded with prasugrel 60 mg and continued with prasugrel only (10 mg once a day) for three months. Aspirin and clopidogrel will be discontinued. At the 3-months follow-up visit, prasugrel (only) will be replaced by aspirin (only) or dual-antiplatelet therapy according to local standard of care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Successful PCI with optimal acute stent implantation results (based on local standard of care by angiography and/or findings from intracoronary imaging and on investigators' discretion) of one or more everolimus-eluting SYNERGY® stent(s). Typically, optimal acute coronary stenting result is a combination of successful stent implantation at the target lesion with absence of significant residual diameter stenosis (<20%), no edge dissection, no thrombus, no major side branch occlusion, "no-reflow", no major stent under-expansion or major stent incomplete apposition.
Key exclusion criteria (14 listed)
- Candidates will be ineligible for enrolment in the study if any of the following conditions apply:
- Left-main disease
- Chronic Total Occlusion
- Bifurcation lesion requiring two stent treatment
- Saphenous or arterial graft
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 |
|---|---|---|
| Prasugrel monotherapyAlso: PCI with the SYNERGY® stentA multicenter, single arm, open-label trial of in patients with chronic stable angina | Drug | single arm |
Primary outcome
Primary Ischemic Endpoint
Time frame: 3 months
Composite of cardiac death, target-vessel myocardial infarction (spontaneous >48 hours) orn definite stent thrombosis
Primary Bleeding Endpoint
Time frame: 3 months
BARC 3 - 5 bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Derived from this study: PubMed 32950419Kogame N, Guimaraes PO, Modolo R, De Martino F, Tinoco J, Ribeiro EE, Kawashima H, Ono M, Hara H, Wang R, Cavalcante R, Moulin B, Falcao BAA, Leite RS, de Almeida Sampaio FB, Morais GR, Meireles GC, Campos CM, Onuma Y, Serruys PW, Lemos PA. Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study. JACC Cardiovasc Interv. 2020 Oct 12;13(19):2251-2262. doi: 10.1016/j.jcin.2020.06.023. Epub 2020 Sep 16.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prasugrel monotherapy in people with Monotherapy After PCI, run by Pedro A. Lemos at 1 site in Brazil.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Mar 2018. 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 Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata M Do val (551126615923, renata.doval@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Ischemic Endpoint (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469856, which also lists 1 linked publication.
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 19 Mar 2018.