Health TrialsbyHealthPanel

PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction

ConditionST-segment Elevation Myocardial Infarction (STEMI)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKindai University

About this trial

The aim of this study is to evaluate the safety of prasugrel monotherapy without aspirin versus 12-month dual antiplatelet therapy (DAPT) in patients with STEMI using platinum-chrome everolimus-eluting stent (PtCr-EES: SYNERGYTM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGYTM)

STEMI patients

Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months

Disqualifiers

Patients taking anticoagulants

Patients under 18 years old

Patients with less than 1 year prognosis

Patients participating in other intervention studies

Trial design

Design model

Parallel

Treatments tested in this trial

  • No aspirin (Prasugurel monotherapy)

    Drug

    12-month prasugrel monotherapy

  • 12-month DAPT

    Drug

    12-month dual antiplatelet therapy with prasugrel and aspirin

Treatment groups

2,258 Participants
are divided into 2 treatment groups
Group A: No aspirin (Prasugrel monotherapy)Active comparator 1 intervention
Group B: 12-month DAPTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular events

Composite of all-cause death, myocardial infarction, or stroke

Time frame
12 months

Secondary outcomes

1

Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

Type 3 or 5 bleeding defined by BARC criteria

Time frame
12 months
2

All-cause death

Death from any cause

Time frame
12 months
3

Cardiovascular death

Death from cardiovascular cause

Time frame
12 months
4

Non-cardiovascular death

Death from non-cardiovascular cause

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kindai University

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
Apply now