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

NCT04360720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3410

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

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 until the end of the study, at Month 12.

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Pedro A Lemos, MD · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2024-11-30
Completion
2024-12-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360720 on ClinicalTrials.gov