Ticagrelor De-escalation Strategy in AMI Patients

ConditionAcute Myocardial Infarction

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age19-80

SponsorDong-A University

About this trial

DAPT de-escalation strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. The EASTYLE trial will evaluate a hybrid DAPT de-escalation strategy (reduced-dose ticagrelor, followed by aspirin early discontinuation) in AMI patients, compared with a conventional DAPT strategy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis with acute myocardial infarction.

Age ≥19 year-old

Successful PCI with ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG).

Provision of informed consent.

Disqualifiers

Any prior event of hemorrhagic stroke or ICH.

Active bleeding (e.g., GI bleeding, ICH) or high-risk of serious bleeding.

Bleeding diathesis or coagulopathy (e.g., hemoglobin ≤ 10 g/dL or platelet count < 100,000/μL, bleeding needing transfusion within 30 days, and so on).

Allergy to stent metal, contrat media, and antiplatelet regimens.

Trial design

Design model

Parallel

Treatments tested in this trial

De-escalation strategy
Drug
De-escalation strategy indicates conventional DAPT (ticagrelor 90 mg twice daily + aspirin 100 mg once daily) for 1 month, followed by de-escalation DAPT (ticagrelor 60 mg twice daily + aspirin 100 mg once daily) between 1 and 3 months. Between 3 and 12 months, patients will be treated with ticagrelor monotherapy (ticagrelor 60 mg twice daily).
Conventional strategy
Drug
Conventional stratetgy indicates conventional DAPT including ticagrelor 90 mg twice daily and aspirin 100 mg once daily during 12 months.

Treatment groups

2,312 Participants

are divided into 2 treatment groups

Group A: De-escalation strategyExperimental treatment 1 intervention

Group B: Conventional strategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Primary endpoint (NACE)

MACCE (all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke) + major bleeding (BARC type 2, 3, or 5 bleeding)

Time frame

12 months

Secondary outcomes

Major adverse cardiac and cerebrovascular events (MACCE)

all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke

Time frame

12 months

Bleeding events

BARC type 2, 3 or 5 bleeding; BARC 3 or 5 bleeding; TIMI major or minor bleeding; GUSTO severe or moderate bleeding; ISTH major bleeding

Time frame

12 months

All-cause death

any mortality

Time frame

12 months

CV death

Death related CV system

Time frame

12 months

Other outcomes

Type of AMI

STEMI vs. NSTEMI

Time frame

12 months

HBR

presence of HBR (high bleeding risk) criteria

Time frame

12 months

presence of diabetes mellitus

Time frame

12 months

CKD

presence of chronic kidney disease

Time frame

12 months

Sponsors and contacts

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Dong-A University

Lead sponsor

Biotronik SE & Co. KG

Collaborator

Samjin Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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