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

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI)

Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
No aspirin (Prasugurel monotherapy)
12-month DAPT
Sponsored by
Kindai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring Acute Coronary Syndrome, Dual AntiPlatelet Therapy, Drug Eluting Stent, Percutaneous Coronary Intervention, ST-elevation myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Patients taking anticoagulants Patients under 18 years old Patients with less than 1 year prognosis Patients participating in other intervention studies

Sites / Locations

  • Kindai University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No aspirin (Prasugrel monotherapy)

12-month DAPT

Arm Description

To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI).

To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).

Outcomes

Primary Outcome Measures

Major adverse cardiovascular events
Composite of all-cause death, myocardial infarction, or stroke

Secondary Outcome Measures

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
All-cause death
Death from any cause
Cardiovascular death
Death from cardiovascular cause
Non-cardiovascular death
Death from non-cardiovascular cause
Myocardial infarction (Periprocedual/ Spontaneous)
Defined by the Academic Research Consortium (ARC)-2
Stroke (Ischemic/ Haemorrhagic)
Including both ischemic and haemorrhagic stroke
Ischemic stroke
Ischemic stroke with symptom lasting over 24 hours
Hemorrhagic stroke
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
Stent thrombosis
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition
Target lesion failure
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization
Target vessel failure
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization
Patient-Oriented Composite Endpoint
All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2
Any target lesion revascularization
Revascularization to the target lesions (including 5mm of both ends of the stent[s]) regardless of PCI or CABG
Clinically-driven target lesion revascularization
Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Non-target lesion revascularization
Revascularization to non-target lesions regardless PCI or CABG
Coronary artery bypass grafting
Any coronary artery bypass grafting
Any target vessel revascularization
Revascularization to the target vessel
Any coronary revascularization
Revascularization regardless of PCI or CABG
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 2 bleeding defined by BARC criteria
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 3 bleeding defined by BARC criteria
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 4 bleeding defined by BARC criteria
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 5 bleeding defined by BARC criteria
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Type 2, 3, or 5 bleeding defined by BARC criteria
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Major bleeding defined by TIMI criteria
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Minor bleeding defined by TIMI criteria
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Major or minor defined by TIMI criteria
Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Severe bleeding defined by GUSTO criteria
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Moderate bleeding defined by GUSTO criteria
Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Moderate or severe bleeding defined by GUSTO criteria
Intracranial bleeding
Intracranial bleeding regardless of spontaneous or trauma
Gastrointestinal bleeding
Bleeding from gastrointestinal tract regardless of severity
Gastrointestinal complaints
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints

Full Information

First Posted
January 19, 2023
Last Updated
February 28, 2023
Sponsor
Kindai University
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05709626
Brief Title
PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
Acronym
PREMIUM
Official Title
PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Anticipated)
Primary Completion Date
January 4, 2025 (Anticipated)
Study Completion Date
January 4, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kindai University
Collaborators
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
In the STOPDAPT-2 ACS trial (NCT03462498), ischemic events (especially myocardial infarction) was significantly increased with 1-month DAPT followed by clopidogrel monotherapy, as compared to 12-month DAPT in patients with acute coronary syndrome (ACS). This was potentially attributable to clopidogrel, instead of prasugrel, which is more potent and has less individual difference in efficacy. On the other hand, previous studies including the STOPDAPT-2 ACS that evaluated the safety and efficacy of monotherapy with a P2Y12 inhibitor without aspirin consistently and significantly reduced the risk of bleeding, compared with standard DAPT. Consequently, there has been growing necessity to establish the safety with P2Y12 inhibitor monotherapy in terms of major adverse cardiovascular events. Therefore, we have planned to evaluate the non-inferiority of P2Y12 inhibitor monotherapy with prasugrel versus standard 12-month DAPT with prasugrel and aspirin in terms of the incidence of major cardiovascular events at 12 months after primary PCI in patients with STEMI using Platinum-Chromium Everolimus Eluting Stent (PtCr-EES; SYNERGYTM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction (STEMI)
Keywords
Acute Coronary Syndrome, Dual AntiPlatelet Therapy, Drug Eluting Stent, Percutaneous Coronary Intervention, ST-elevation myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No aspirin (Prasugrel monotherapy)
Arm Type
Active Comparator
Arm Description
To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI).
Arm Title
12-month DAPT
Arm Type
Active Comparator
Arm Description
To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).
Intervention Type
Drug
Intervention Name(s)
No aspirin (Prasugurel monotherapy)
Other Intervention Name(s)
Experimental arm
Intervention Description
12-month prasugrel monotherapy
Intervention Type
Drug
Intervention Name(s)
12-month DAPT
Other Intervention Name(s)
Reference arm
Intervention Description
12-month dual antiplatelet therapy with prasugrel and aspirin
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events
Description
Composite of all-cause death, myocardial infarction, or stroke
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 3 or 5 bleeding defined by BARC criteria
Time Frame
12 months
Title
All-cause death
Description
Death from any cause
Time Frame
12 months
Title
Cardiovascular death
Description
Death from cardiovascular cause
Time Frame
12 months
Title
Non-cardiovascular death
Description
Death from non-cardiovascular cause
Time Frame
12 months
Title
Myocardial infarction (Periprocedual/ Spontaneous)
Description
Defined by the Academic Research Consortium (ARC)-2
Time Frame
12 months
Title
Stroke (Ischemic/ Haemorrhagic)
Description
Including both ischemic and haemorrhagic stroke
Time Frame
12 months
Title
Ischemic stroke
Description
Ischemic stroke with symptom lasting over 24 hours
Time Frame
12 months
Title
Hemorrhagic stroke
Description
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
Time Frame
12 months
Title
Stent thrombosis
Description
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition
Time Frame
12 months
Title
Target lesion failure
Description
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization
Time Frame
12 months
Title
Target vessel failure
Description
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization
Time Frame
12 months
Title
Patient-Oriented Composite Endpoint
Description
All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2
Time Frame
12 months
Title
Any target lesion revascularization
Description
Revascularization to the target lesions (including 5mm of both ends of the stent[s]) regardless of PCI or CABG
Time Frame
12 months
Title
Clinically-driven target lesion revascularization
Description
Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Time Frame
12 months
Title
Non-target lesion revascularization
Description
Revascularization to non-target lesions regardless PCI or CABG
Time Frame
12 months
Title
Coronary artery bypass grafting
Description
Any coronary artery bypass grafting
Time Frame
12 months
Title
Any target vessel revascularization
Description
Revascularization to the target vessel
Time Frame
12 months
Title
Any coronary revascularization
Description
Revascularization regardless of PCI or CABG
Time Frame
12 months
Title
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 2 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 3 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 4 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 5 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 2, 3, or 5 bleeding defined by BARC criteria
Time Frame
12 months
Title
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Major bleeding defined by TIMI criteria
Time Frame
12 months
Title
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Minor bleeding defined by TIMI criteria
Time Frame
12 months
Title
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Major or minor defined by TIMI criteria
Time Frame
12 months
Title
Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Description
Severe bleeding defined by GUSTO criteria
Time Frame
12 months
Title
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Description
Moderate bleeding defined by GUSTO criteria
Time Frame
12 months
Title
Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Description
Moderate or severe bleeding defined by GUSTO criteria
Time Frame
12 months
Title
Intracranial bleeding
Description
Intracranial bleeding regardless of spontaneous or trauma
Time Frame
12 months
Title
Gastrointestinal bleeding
Description
Bleeding from gastrointestinal tract regardless of severity
Time Frame
12 months
Title
Gastrointestinal complaints
Description
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients taking anticoagulants Patients under 18 years old Patients with less than 1 year prognosis Patients participating in other intervention studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuniaki Takahashi, MD, PhD
Phone
+81-72-366-0221
Email
kuniaki.t.0125@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaku Nakazawa, MD, PhD
Organizational Affiliation
Kindai University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kindai University Faculty of Medicine
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaku Nakazawa, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kuniaki Takahashi, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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