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

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).

Study Overview

• Status: Recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Drug: No aspirin (Prasugurel monotherapy); Drug: 12-month DAPT

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).

• Study Type: Interventional
• Enrollment (Anticipated): 2258
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Recruiting
      • Kindai University Faculty of Medicine
      • Contact: Gaku Nakazawa, MD, PhD
      • Contact: Kuniaki Takahashi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No aspirin (Prasugrel monotherapy); To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI).	Drug: No aspirin (Prasugurel monotherapy); 12-month prasugrel monotherapy; Other Names: Experimental arm
Active Comparator: 12-month DAPT; To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI).	Drug: 12-month DAPT; 12-month dual antiplatelet therapy with prasugrel and aspirin; Other Names: Reference arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	Composite of all-cause death, myocardial infarction, or stroke	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic stroke	Ischemic stroke with symptom lasting over 24 hours	12 months
Clinically-driven target lesion revascularization	Target lesion revascularization with the anginal symptoms or the positive test for ischemia	12 months
Coronary artery bypass grafting	Any coronary artery bypass grafting	12 months
Any target vessel revascularization	Revascularization to the target vessel	12 months
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 2 bleeding defined by BARC criteria	12 months
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 3 bleeding defined by BARC criteria	12 months
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 4 bleeding defined by BARC criteria	12 months
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 5 bleeding defined by BARC criteria	12 months
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 2, 3, or 5 bleeding defined by BARC criteria	12 months
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Major bleeding defined by TIMI criteria	12 months
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Minor bleeding defined by TIMI criteria	12 months
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Major or minor defined by TIMI criteria	12 months
Intracranial bleeding	Intracranial bleeding regardless of spontaneous or trauma	12 months
Gastrointestinal bleeding	Bleeding from gastrointestinal tract regardless of severity	12 months
Gastrointestinal complaints	Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints	12 months
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	12 months
All-cause death	Death from any cause	12 months
Cardiovascular death	Death from cardiovascular cause	12 months
Non-cardiovascular death	Death from non-cardiovascular cause	12 months
Myocardial infarction (Periprocedual/ Spontaneous)	Defined by the Academic Research Consortium (ARC)-2	12 months
Stroke (Ischemic/ Haemorrhagic)	Including both ischemic and haemorrhagic stroke	12 months
Hemorrhagic stroke	Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma	12 months
Stent thrombosis	Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition	12 months
Target lesion failure	Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization	12 months
Target vessel failure	Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization	12 months
Patient-Oriented Composite Endpoint	All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2	12 months
Any target lesion revascularization	Revascularization to the target lesions (including 5mm of both ends of the stent[s]) regardless of PCI or CABG	12 months
Non-target lesion revascularization	Revascularization to non-target lesions regardless PCI or CABG	12 months
Any coronary revascularization	Revascularization regardless of PCI or CABG	12 months
Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria	Severe bleeding defined by GUSTO criteria	12 months
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria	Moderate bleeding defined by GUSTO criteria	12 months
Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria	Moderate or severe bleeding defined by GUSTO criteria	12 months

Collaborators and Investigators

• Sponsor: Kindai University
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2023
• Primary Completion (Anticipated): January 4, 2025
• Study Completion (Anticipated): January 4, 2028

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Drug Eluting Stent; Acute Coronary Syndrome; ST-elevation myocardial infarction; Dual AntiPlatelet Therapy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: Y0140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No