CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,248 enrolled
Drug / intervention
Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04753749
NCT04753749N/ACompleted

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

MicroPort CRM·interventional·Posted Feb 15, 2021·Updated Jul 29, 2025

In Brief

A clinical study evaluating Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin) and Standard DAPT for Myocardial Infarction, Acute and Coronary Artery Disease. Completed, enrolled 2,248 participants across 40 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, Italy, Netherlands, Portugal, Spain

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 15, 2021
Enrollment StartMar 25, 2021
Primary CompletionMay 5, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.4 years ago

Interventions

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

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

Standard DAPTdrug

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