An interventional study of Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin) and Standard DAPT in Myocardial Infarction, Acute and Coronary Artery Disease, sponsored by MicroPort CRM. Completed at 40 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by MicroPort CRM (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment
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.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's enrollment of 2,248 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →MicroPort CRM is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
First submitted after MicroPort CRM became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (General):
Inclusion Criteria (Procedural/angiographic):
All treated lesions:
Exclusion Criteria (General):
Exclusion Criteria (Procedural/Angiographic):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)
Drug: Standard DAPT
Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months
Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure
Net Adverse Clinical and Cerebral Events (NACCE)
(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)
Time frame: 11 months post randomization
Bleeding events
(Number of participants with first occurrence of) bleeding events (BARC 2,3 or 5)
Time frame: 11 months post randomization
All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke
(Number of participants with first occurrence of) all-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke
Time frame: At 1 month, 6 months and 12 months
Primary endpoint component 5 - BARC 3 and 5 bleeding events
(Number of participants with first occurrence of) BARC 3 and 5 bleeding events
Time frame: At 1 month, 6 months and 12 months
All-cause death or non-fatal myocardial infarction
(Number of patients with first occurrence of) all-cause death or non-fatal myocardial infarction
Time frame: At 1 month, 6 months and 12 months
Major Adverse Cardiac and Cerebral Events (MACCE) - Patient
Patient-oriented composite of major adverse cardiac and cerebral events (MACCE) including all-cause death, myocardial infarction, definite/probable stent thrombosis, any stroke, any Ischemia driven repeat revascularization, or BARC bleeding events (type 2, 3, or 5)
Time frame: At 1 month, 6 months and 12 months
Target Lesion Failure - Device
Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization)
Time frame: At 1 month, 6 months and 12 months
Major Adverse Cardiac and Cerebral events (MACE) - Events
Number of Major Adverse Cardiac and Cerebral events (MACE)
Time frame: At 1 Month, 6 months and 12 months
Primary endpoint component 3 - Stent thrombosis
Definite or probable stent thrombosis
Time frame: At 1 months, 6 months and 12 months
Main secondary endpoint component 2 - BARC 3 events
(Number of patients with occurrence of) BARC 3 events
Time frame: At 1 month, 6 months and 12 months
Main secondary endpoint component 3 - BARC 5 events
(Number of patients with occurrence of) BARC 5 events
Time frame: At 1 month, 6 months and 12 months
Main secondary endpoint component 1 - BARC 2 events
(Number of patients with occurrence of) BARC 2 events
Time frame: At 1 month, 6 months and 12 months
Cardiovascular death
Number of patients with cardiovascular death
Time frame: At 1 months, 6 months and 12 months
Cardiac death
Number of patients with cardiac death
Time frame: At 1 month, 6 months and 12 months
Non cardiac death
Number of patients with non cardiac death
Time frame: At 1 month, 6 months and 12 months
Primary endpoint component 2 - Myocardial infarction
Number of patients with myocardial infarction
Time frame: At 1 month, 6 months and 12 months
Cardiac death or non-fatal myocardial infarction
(Number of patients with first occurrence of) cardiac death or non-fatal myocardial infarction
Time frame: At 1 month, 6 months and 12 months
Cardiac death, myocardial infarction, or definite/probable stent thrombosis
(Number of patients with first occurrence of) cardiac death, myocardial infarction, or definite/probable stent thrombosis
Time frame: At 1 month, 6 months and 12 months
Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke
(Number of patients with first occurrence of) cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke
Time frame: 1 month, 6 months and 12 months
Primary endpoint component 4 - Ischemic stroke
(Number of patients with occurrence of) ischemic stroke
Time frame: At 1 month, 6 months and 12 months
Haemorrhagic stroke
(Number of patients with occurrence of) haemorrhagic stroke
Time frame: At 1 month, 6 months and 12 months
Ischemia-driven target lesion revascularization
(Number of patients with) Ischemia-driven target lesion revascularization
Time frame: At 1 month, 6 months and 12 months
Ischemia-driven target vessel revascularization
(Number of patients with) Ischemia-driven target vessel revascularization
Time frame: At 1 month, 6 months and 12 months
Cardiovascular death, myocardial infarction, or ischemic stroke
(Number of patients with first occurrence of) cardiovascular death, myocardial infarction, or ischemic stroke
Time frame: At 1 month, 6 months and 12 months
Primary endpoint component 1 - All cause death
(Number of patients with) all cause death
Time frame: At 1 month, 6 months and 12 months
Primary endpoint component 2 - Myocardial infarction
(Number of patients with occurrence of) myocardial infarction
Time frame: At 1 month, 6 months and 12 months
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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