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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Myocardial Infarction, Acute
• Interventions: Drug: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin); Drug: Standard DAPT

• Registration Number: NCT04753749
• Lead Sponsor: MicroPort CRM

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-15
• Study Start: 2021-03-25
• Status Verified: 2025-05
• Primary Completion: 2025-05-05
• Study Completion: 2025-05-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2248

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shortened DAPT followed by P2Y12 inhibitor monotherapy	Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)	-
Dual Antiplatelet Therapy	Standard DAPT	-

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical and Cerebral Events (NACCE)	11 months post randomization	(Number of participants with first occurrence of) NACCE, defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or bleeding events (BARC type 3 or 5)
Bleeding events	11 months post randomization	(Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5)

Trial Locations

Locations (40)

Maastad University Hospital; 🇳🇱 Rotterdam, Netherlands

Giovanni Paolo II; 🇮🇹 Ragusa, Italy

Clinic Hospital Barcelona; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

CHU Caen; 🇫🇷 Caen, France

Hospital Universitario de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Spain

Hôpital Jacques Cartier; 🇫🇷 Massy, France

CH Chartres; 🇫🇷 Chartres, France

CHU Annecy; 🇫🇷 Annecy, France

Universitätsklinikum; 🇦🇹 St Pölten, Austria

Clinique Millénaire; 🇫🇷 Montpellier, France

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Netherlands

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, Netherlands

Tergooi MC; 🇳🇱 Blaricum, Netherlands

CHU Nîmes; 🇫🇷 Nîmes, France

CHU Reims; 🇫🇷 Reims, France

CHU Toulouse; 🇫🇷 Toulouse, France

Humanitas - Gavazzeni; 🇮🇹 Bergamo, Italy

AOU Federico II; 🇮🇹 Napoli, Italy

CH Cherbourg; 🇫🇷 Cherbourg, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Clinique Roseraie; 🇫🇷 Aubervilliers, France

CH Haguenau; 🇫🇷 Haguenau, France

CH Bastia; 🇫🇷 Bastia, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Lille; 🇫🇷 Lille, France

CHU La Timone; 🇫🇷 Marseille, France

Clinica Montevergine; 🇮🇹 Mercogliano, Italy

Niguarda; 🇮🇹 Milan, Italy

Policlinico Universitario; 🇮🇹 Padova, Italy

Haga Ziekenhuis; 🇳🇱 The Hague, Netherlands

Hospital General Universitario; 🇪🇸 Alicante, Spain

Puerta del mar; 🇪🇸 Cadiz, Spain

CH St Joseph/St Luc; 🇫🇷 Lyon, France

CHU Montpellier; 🇫🇷 Montpellier, France

Hosp. Doctor Lucus Augusti; 🇪🇸 Lugo, Spain

Clinique St Hilaire; 🇫🇷 Rouen, France

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Santa Maria; 🇵🇹 Lisbon, Portugal