Acetyl Salicylic Elimination Trial: The ASET Pilot Study

NCT03469856 | Unknown DMC

• 1 other identifier: DSC 4579/17/079
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Monotherapy After PCI

Outcome Measures

Primary Outcomes (2)

• Primary Ischemic Endpoint

  Composite of cardiac death, target-vessel myocardial infarction (spontaneous \>48 hours) orn definite stent thrombosis

  3 months

• Primary Bleeding Endpoint

  BARC 3 - 5 bleeding

  3 months

Study Arms (1)

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.

Drug: Prasugrel monotherapy

Interventions

Prasugrel monotherapy DRUG

A multicenter, single arm, open-label trial of in patients with chronic stable angina

Also known as: PCI with the SYNERGY® stent

single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Pedro A. Lemos: lead
• Imperial College London: collaborator
• Cardialysis B.V.: collaborator

Study Sites (1)

Heart Institute - InCor

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 32950419 DERIVED

Central Study Contacts

Renata M Do val

CONTACT

551126615923; renata.doval@yahoo.com.br

Patrícia Guimaraes, Phd MD

CONTACT

551126615495; patricia.guimaraes@incor.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 19, 2018
• Study Start: February 22, 2018
• Primary Completion: July 15, 2019
• Study Completion: August 15, 2019
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

BR (1)