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Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion (ATTEMPT)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Complex Coronary Lesion

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ① Subject must be at least 19 years of age
  • ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
  • ③ Patients undergoing elective PCI as follows:

    1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size
    2. Chronic total occlusion (≥3 months) as target lesion
    3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)
    4. Long coronary lesions (expected stent length ≥38 mm)
    5. Multi-vessel PCI (≥2 vessels treated at one PCI session)
    6. Multiple stent needed (≥3 stents per patient)
    7. In-stent restenosis lesion as target lesion
    8. Severely calcified lesion (encircling calcium in angiography)
    9. Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery

Exclusion Criteria:

  • ① Hemodynamic instability or cardiogenic shock
  • ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.)
  • ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke
  • ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel)
  • ⑤ Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  • ⑥ Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • ⑦ Patients presenting with biomarker positive acute coronary syndrome
  • ⑧ Patients chronically taking prasugrel or ticagrelor (≥1 week)
  • ⑨ Subjects ≥75 years of age or <60 kg of body weight
  • ⑩ Patients taking warfarin or novel oral anticoagulants (dabigatran, rivaroxaban, edoxaban, or apixaban)

    • Eligible patients will be randomly assigned to treatment arms, stratified by participating centers, presence of diabetes mellitus, and stent types.

Sites / Locations

  • Samsung Medical CenterRecruiting
  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prasugrel plus Aspirin arm

Clopidogrel plus Aspirin arm

Arm Description

Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of prasugrel 60 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus prasugrel 10 mg once daily* will be given for one year. * Based on previous studies including PRASFIT-ACS (PRASugrel compared with clopidogrel For Japanese patIenTs with ACS undergoing PCI) or TRILOGY ACS (The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes), maintenance dose can be reduced to 5 mg once daily in patients with high bleeding risk or by investigator's medical judgement.

Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of clopidogrel 600 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for one year.

Outcomes

Primary Outcome Measures

Major adverse cardiac events (MACE)
A composite of death, myocardial infarction, or stent thrombosis

Secondary Outcome Measures

All-cause death
Death by any cause
Cardiac death
Death by cardiac cause
Myocardial infarction
Myocardial infarction
Stent thrombosis
Definite or probable stent thrombosis
Target lesion revascularization
Repeat revascularization for target lesion of index PCI
Target vessel revascularization
Repeat revascularization for target vessel of index PCI
Any revascularization
Any repeat revascularization
A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
A composite of all-cause death/myocardial infarction
A composite of all-cause death/myocardial infarction
A composite of cardiac death/myocardial infarction
A composite of cardiac death/myocardial infarction
Cerebrovascular accident
Cerebrovascular accident
A composite of all-cause death/myocardial infarction/cerebrovascular accident
A composite of all-cause death/myocardial infarction/cerebrovascular accident
A composite of cardiac death/myocardial infarction/cerebrovascular accident
A composite of cardiac death/myocardial infarction/cerebrovascular accident
A composite of cardiac death/myocardial infarction/stent thrombosis
A composite of cardiac death/myocardial infarction/stent thrombosis
Bleeding by BARC types 3 or 5
Bleeding defined by Bleeding Academic Research Consortium (BARC) types 3 or 5
Bleeding by BARC types 2, 3, or 5
Bleeding defined by BARC types 2, 3 or 5
Net adverse clinical events
MACE + bleeding by BARC types 3 or 5

Full Information

First Posted
July 8, 2019
Last Updated
April 12, 2023
Sponsor
Samsung Medical Center
Collaborators
Inje University Ilsan Paik Hospital, Seoul St. Mary's Hospital, Mediplex Sejong Hospital, Chonnam National University Hospital, Sejong General Hospital, Wonkwang University Hospital, Gachon University Gil Medical Center, Keimyung University Dongsan Medical Center, Chungbuk National University Hospital, Yeungnam University Hospital, Chungnam National University Hospital, Wonju Severance Christian Hospital, Konkuk University Chungju Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Dankook University, Incheon St.Mary's Hospital, Gyeongsang National University Hospital, Soonchunhyang University Hospital, Ewha Womans University Seoul Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04014803
Brief Title
Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion
Acronym
ATTEMPT
Official Title
Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Inje University Ilsan Paik Hospital, Seoul St. Mary's Hospital, Mediplex Sejong Hospital, Chonnam National University Hospital, Sejong General Hospital, Wonkwang University Hospital, Gachon University Gil Medical Center, Keimyung University Dongsan Medical Center, Chungbuk National University Hospital, Yeungnam University Hospital, Chungnam National University Hospital, Wonju Severance Christian Hospital, Konkuk University Chungju Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Dankook University, Incheon St.Mary's Hospital, Gyeongsang National University Hospital, Soonchunhyang University Hospital, Ewha Womans University Seoul Hospital

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
This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions.
Detailed Description
Over the past several decades, dual antiplatelet therapy (DAPT) with the combination of aspirin and a P2Y12 inhibitor has become an essential treatment in patients undergoing percutaneous coronary intervention (PCI) to reduce ischemic events. Although the optimal duration of DAPT still remains controversial in patients with coronary artery disease, the recommended duration of maintenance of DAPT for patients undergoing PCI with drug-eluting stent is ≥12 months for those with acute coronary syndrome (ACS), and ≥6 months for those with stable coronary artery disease according to the current guidelines. However, individualized approach based on ischemic versus bleeding risks assessment is needed to determine the optimal duration of DAPT in various population. Several studies reported that patients undergoing PCI for complex lesions had significantly higher rates of ischemic events than those with non-complex lesions. Moreover, prolonged DAPT of aspirin and clopidogrel more than 1 year significantly reduced the risk of cardiac ischemic events up to 44% in patients undergoing PCI for complex coronary lesions, and the current guideline recommends prolonged DAPT duration may be considered in patients undergoing complex PCI. Apart from prolonged use of DAPT, use of more potent P2Y12 inhibitor than clopidogrel may be another strategy to reduce ischemic events in patients undergoing PCI for complex coronary lesions. Prasugrel, a new thienopyridine, inhibits platelet aggregation more rapidly and potently than clopidogrel. In the TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel) study, prasugrel reduced ischemic events compared with clopidogrel in patients with acute coronary syndrome. Moreover, low dose prasugrel also reduced ischemic events without an excessive bleeding risk in Japanese population. Therefore, DAPT of aspirin and prasugrel would reduce recurrent ischemic events than DAPT of aspirin and clopidogrel in patients undergoing PCI for complex lesions, a high risk group of ischemic events, even when they do not present with myocardial infarction. So far, there have been no data on this issue. The aim of the SMART-ATTEMPT (Aspirin and a PoTent P2Y12 inhibitor versus aspirin and clopidogrel Therapy in patients undergoing Elective percutaneous coronary intervention for coMPlex lesion Treatment) trial is to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective PCI for complex lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Complex Coronary Lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel plus Aspirin arm
Arm Type
Active Comparator
Arm Description
Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of prasugrel 60 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus prasugrel 10 mg once daily* will be given for one year. * Based on previous studies including PRASFIT-ACS (PRASugrel compared with clopidogrel For Japanese patIenTs with ACS undergoing PCI) or TRILOGY ACS (The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes), maintenance dose can be reduced to 5 mg once daily in patients with high bleeding risk or by investigator's medical judgement.
Arm Title
Clopidogrel plus Aspirin arm
Arm Type
Active Comparator
Arm Description
Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of clopidogrel 600 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for one year.
Intervention Type
Drug
Intervention Name(s)
Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
Other Intervention Name(s)
Prasugrel plus Aspirin or Clopidogrel plus Aspirin
Intervention Description
Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin will be given according to the allocated arms in patients undergoing elective percutaneous coronary intervention for complex coronary lesion Prasugrel plus Aspirin arm Clopidogrel plus Aspirin arm
Primary Outcome Measure Information:
Title
Major adverse cardiac events (MACE)
Description
A composite of death, myocardial infarction, or stent thrombosis
Time Frame
1-year after randomization
Secondary Outcome Measure Information:
Title
All-cause death
Description
Death by any cause
Time Frame
1-year after randomization
Title
Cardiac death
Description
Death by cardiac cause
Time Frame
1-year after randomization
Title
Myocardial infarction
Description
Myocardial infarction
Time Frame
1-year after randomization
Title
Stent thrombosis
Description
Definite or probable stent thrombosis
Time Frame
1-year after randomization
Title
Target lesion revascularization
Description
Repeat revascularization for target lesion of index PCI
Time Frame
1-year after randomization
Title
Target vessel revascularization
Description
Repeat revascularization for target vessel of index PCI
Time Frame
1-year after randomization
Title
Any revascularization
Description
Any repeat revascularization
Time Frame
1-year after randomization
Title
A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
Description
A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
Time Frame
1-year after randomization
Title
A composite of all-cause death/myocardial infarction
Description
A composite of all-cause death/myocardial infarction
Time Frame
1-year after randomization
Title
A composite of cardiac death/myocardial infarction
Description
A composite of cardiac death/myocardial infarction
Time Frame
1-year after randomization
Title
Cerebrovascular accident
Description
Cerebrovascular accident
Time Frame
1-year after randomization
Title
A composite of all-cause death/myocardial infarction/cerebrovascular accident
Description
A composite of all-cause death/myocardial infarction/cerebrovascular accident
Time Frame
1-year after randomization
Title
A composite of cardiac death/myocardial infarction/cerebrovascular accident
Description
A composite of cardiac death/myocardial infarction/cerebrovascular accident
Time Frame
1-year after randomization
Title
A composite of cardiac death/myocardial infarction/stent thrombosis
Description
A composite of cardiac death/myocardial infarction/stent thrombosis
Time Frame
1-year after randomization
Title
Bleeding by BARC types 3 or 5
Description
Bleeding defined by Bleeding Academic Research Consortium (BARC) types 3 or 5
Time Frame
1-year after randomization
Title
Bleeding by BARC types 2, 3, or 5
Description
Bleeding defined by BARC types 2, 3 or 5
Time Frame
1-year after randomization
Title
Net adverse clinical events
Description
MACE + bleeding by BARC types 3 or 5
Time Frame
1-year after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ① Subject must be at least 19 years of age ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure ③ Patients undergoing elective PCI as follows: True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size Chronic total occlusion (≥3 months) as target lesion PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions) Long coronary lesions (expected stent length ≥38 mm) Multi-vessel PCI (≥2 vessels treated at one PCI session) Multiple stent needed (≥3 stents per patient) In-stent restenosis lesion as target lesion Severely calcified lesion (encircling calcium in angiography) Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery Exclusion Criteria: ① Hemodynamic instability or cardiogenic shock ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.) ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel) ⑤ Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study ⑥ Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment) ⑦ Patients presenting with biomarker positive acute coronary syndrome ⑧ Patients chronically taking prasugrel or ticagrelor (≥1 week) ⑨ Subjects ≥75 years of age or <60 kg of body weight ⑩ Patients taking warfarin or novel oral anticoagulants (dabigatran, rivaroxaban, edoxaban, or apixaban) Eligible patients will be randomly assigned to treatment arms, stratified by participating centers, presence of diabetes mellitus, and stent types.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Yong Hahn, MD, PhD
Phone
82-2-3410-1246
Email
ichjy1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ki hong Choi, MD, PhD
Phone
82-2-3410-3419
Email
cardiokh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, MD, PhD
Phone
82-2-3410-6653
Email
ichjy1@gmail.com
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion

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