MedTrace Logo

Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

NCT04753749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2248

Last updated 2025-07-29

No results posted yet for this study

Summary

The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. 1 month duration) followed by P2Y12 inhibitor monotherapy for the next 11 months. It is hypothesized that in the setting of clinically stable, low to moderate complexity acute Myocardial Infarction patients, a modern approach combining a stent with high biocompatibility feature, complete revascularization strategy and modified antiplatelet therapy may be associated with similar outcomes, or even a significant benefit compared with guidelines-recommended 12-month DAPT. This benefit could be driven by a reduced risk in significant bleeding events, while keeping a comparable protection against ischemic risk. Enrolled subjects will be randomized in a 1:1 ratio to either cessation of aspirin at 1 months, either continuation of DAPT. Selection of the P2Y12 inhibitor agent is left to investigator judgment but has to be in line with the current ESC guidelines. Subjects treated with the Firehawk or Firehawk Liberty coronary stent will be included in this study.

Conditions

Interventions

DRUG

Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)

Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months

DRUG

Standard DAPT

Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Giuseppe Tarantini, Pr · Padova University Hospital, Italy

  • Cayla Guillaume, Pr · Nîmes University Hospital, France

  • Smits Peter, Pr · Maastad University Hospital, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2025-05-05
Completion
2025-05-05

Countries

  • Austria
  • France
  • Italy
  • Netherlands
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT04753749 on ClinicalTrials.gov