Trials Sponsors Conditions Drugs Pricing

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 monotherapyDrug

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

Also known as: PCI with the SYNERGY® stent

single arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Study Sites (1)

Heart Institute - InCor

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Expedito Ribeiro, MD PhDCONTACT+55 11 2661 5614 expribeiro@incor.usp.br

Patricia Pereira, RNCONTACT+55 11 26624030 patricia.pereira@incor.usp.br

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: 32950419DERIVED

Central Study Contacts

Renata M Do val

CONTACT

551126615923 renata.doval@yahoo.com.br

Patrícia Guimaraes, Phd MD

CONTACT

551126615495

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

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 19, 2018

Study Start

February 22, 2018

Actual (reported)

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.

Acetyl Salicylic Elimination Trial: The ASET Pilot Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

single arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

single arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations