Percutaneous Coronary Intervention Followed by Antiplatelet Monotherapy in the Setting of Acute Coronary Syndromes

Phase 3

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Antiplatelet Monotherapy

• Registration Number: NCT04360720
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

Phase-3, randomized, multicenter, parallel-group study with blind evaluation of endpoints and intention-to-treat analysis.

The general purpose of the study is evaluate the non-inferiority hypothesis for ischemic events and the superiority hypothesis for bleeding events resulting from platelet P2Y12 receptor inhibitors given as monotherapy in comparison with conventional dual antiplatelet therapy in acute coronary syndrome patients treated with percutaneous coronary intervention in the context of the Unified Health System in Brazil.

Detailed Description

Based on current scientific evidence, acute coronary syndrome subjects should be treated with dual antiplatelet therapy, which consists of the association of acetylsalicylic acid with an oral antagonist of platelet P2Y12 receptor. Clinical trials have shown that dual antiplatelet therapy reduces ischemic events, despite of increasing the risk of bleeding complications. Because dual antiplatelet therapy has a positive net effect, such an approach is currently recommended by international guidelines and recognized as the therapy of choice for acute coronary syndrome subjects. It is known that the acetylsalicylic acid dose is directly proportional to the bleeding risk. However, so far, all new antiplatelet drugs have been tested and used in association with acetylsalicylic acid for a varying period of time. This study is carried out in such context and intends to evaluate the clinical performance of new inhibitors of platelet P2Y12 receptor given solely, as monotherapy, to acute coronary syndrome patients, to test the hypothesis that an antithrombotic monotherapy with such agents (i.e., acetylsalicylic acid withdrawal) sustains efficacy by preventing ischemic complications while reducing the bleeding potential of this drug dosage regimens. It is a Phase-3, randomized, multicenter, parallel-group study with blind evaluation of endpoints and intention-to-treat analysis. Subjects with acute coronary syndrome treated with a successful percutaneous coronary intervention will be enrolled. The general purpose of the study is to test the non-inferiority hypothesis for ischemic events and the superiority hypothesis for bleeding events resulting from platelet P2Y12 receptor inhibitors given as monotherapy in comparison with conventional dual antiplatelet therapy in the context of the Unified Health System in Brazil.

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Study Start: 2020-10-15
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3410

Inclusion Criteria

Subjects must meet all the criteria below:

1. Age >=18 years;
2. Acute coronary syndrome with last symptoms < 24 hours before hospital admission;
3. Successful percutaneous coronary intervention(s) of all target lesions (culprit and non-culprit) with new-generation drug-eluting stents;
4. Length of stay in hospital at randomization < 96 hours;
5. Subjects will be informed about the nature of the study and must agree to comply and give an informed consent in writing using a form approved in advance by the local Ethics Committee.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded:

1. Acute coronary syndrome on index admission treated conservatively or with unsuccessful percutaneous intervention or coronary artery bypass graft;
2. Presence of residual lesions which are likely to require future treatment in the next 12 months;
3. Fibrinolytic therapy < 24 hour before randomization;
4. Need of oral anticoagulation with warfarin or new anticoagulants;
5. Chronic bleeding diathesis;
6. Active or recent major bleeding (in-hospital);
7. Prior intracranial hemorrhage;
8. Ischemic stroke < 30 days;
9. Presence of brain arteriovenous malformation;
10. Index event of non-atherothrombotic etiology (i.e., stent thrombosis, in-stent restenosis, coronary embolism, spontaneous coronary artery dissection, myocardial ischemia due to supply/demand imbalance);
11. Potential or scheduled cardiac or non-cardiac surgery in the next 12 months;
12. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3;
13. Total white blood count < 3,000 cells/mm3;
14. Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C);
15. Receiver of heart transplant;
16. Known allergies or intolerance to acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
17. Subject with life expectation lower than 1 year;
18. Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation in the study;
19. Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.
20. Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antiplatelet Monotherapy	Antiplatelet Monotherapy	All subjects randomized to the Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization. Subjects randomized to the Monotherapy Group will be treated with ticagrelor or prasugrel alone for 12 months. Ticagrelor alone (90 mg twice daily) Or Prasugrel alone (5 or 10 mg once daily)
Antiplatelet Monotherapy	Antiplatelet Monotherapy	All subjects randomized to the Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization. Subjects randomized to the Monotherapy Group will be treated with ticagrelor or prasugrel alone for 12 months. Ticagrelor alone (90 mg twice daily) Or Prasugrel alone (10 mg once daily)

Primary Outcome Measures

Name	Time	Method
Composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularization.	12 months	Co-Primary Efficacy Endpoint (non-inferiority hypothesis)
Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding event	12 months	Co-Primary Safety Endpoint (superiority hypothesis)

Secondary Outcome Measures

Name	Time	Method
Sudden death	30 days	Sudden death
Myocardial Infarction	12 months	Myocardial Infarction
Cost-effectiveness ratio	12 months	Cost-effectiveness ratio
Net adverse clinical events (occurrence of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, BARC 2, 3 or 5 bleeding)	12 months	Net adverse clinical events (occurrence of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, BARC 2, 3 or 5 bleeding)
BARC 1-5 type bleeding	12 months	BARC 1-5 type bleeding
All-cause death, cardiovascular death and non-cardiovascular death	12 months	All-cause death, cardiovascular death and non-cardiovascular death
Stroke	12 months	Stroke
Stent thrombosis	12 months	Stent thrombosis
Unscheduled invasive coronary treatment	12 months	Unscheduled invasive coronary treatment

Trial Locations

Locations (50)

Hospital Ana Nery; 🇧🇷 Salvador, BA, Brazil

Hospital de Messejana Dr. Carlos Alberto Studart Gomes; 🇧🇷 Fortaleza, CE, Brazil

Hospital de Base de Brasília; 🇧🇷 Brasília, DF, Brazil

Instituto Aramari APO; 🇧🇷 Brasília, DF, Brazil

Instituto Cardiovascular de Linhares; 🇧🇷 Linhares, ES, Brazil

Hospital Evangélico de Vila Velha; 🇧🇷 Vila Velha, ES, Brazil

Hospital Santa Casa de Misericórdia de Vitória; 🇧🇷 Vitória, ES, Brazil

Hospital Municipal Aparecida de Goiania; 🇧🇷 Goiânia, GO, Brazil

Universidade Federal de Goiás; 🇧🇷 Goiânia, GO, Brazil

CASSEMS; 🇧🇷 Campo Grande, Mato Grosso do Sul, Brazil

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