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

Coronary Artery Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04014803
• Other study ID #: ATTEMPT16453143
• Status: Recruiting
• Phase: Phase 4
• Start date: January 13, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Samsung Medical Center
• Contact: Joo-Yong Hahn, MD, PhD
• Phone: 82-2-3410-1246
• Email: ichjy1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• ? Subject must be at least 19 years of age

• ? 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

• ? 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:

• ? Hemodynamic instability or cardiogenic shock

• ? Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.)

• ? Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke

• ? Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel)

• ? Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

• ? 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)

• ? Patients presenting with biomarker positive acute coronary syndrome

• ? Patients chronically taking prasugrel or ticagrelor (=1 week)

• ? Subjects =75 years of age or <60 kg of body weight

• ? 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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (20)

Lead Sponsor

Collaborator

Samsung Medical Center

Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Chungbuk National University Hospital, Chungnam National University Hospital, Dankook University, Ewha Womans University Seoul Hospital, Gachon University Gil Medical Center, Gyeongsang National University Hospital, Incheon St.Mary's Hospital, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center, Konkuk University Chungju Hospital, Mediplex Sejong Hospital, Sejong General Hospital, Seoul St. Mary's Hospital, Soonchunhyang University Hospital, Wonju Severance Christian Hospital, Wonkwang University Hospital, Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACE)	A composite of death, myocardial infarction, or stent thrombosis	1-year after randomization
Secondary	All-cause death	Death by any cause	1-year after randomization
Secondary	Cardiac death	Death by cardiac cause	1-year after randomization
Secondary	Myocardial infarction	Myocardial infarction	1-year after randomization
Secondary	Stent thrombosis	Definite or probable stent thrombosis	1-year after randomization
Secondary	Target lesion revascularization	Repeat revascularization for target lesion of index PCI	1-year after randomization
Secondary	Target vessel revascularization	Repeat revascularization for target vessel of index PCI	1-year after randomization
Secondary	Any revascularization	Any repeat revascularization	1-year after randomization
Secondary	A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization	A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization	1-year after randomization
Secondary	A composite of all-cause death/myocardial infarction	A composite of all-cause death/myocardial infarction	1-year after randomization
Secondary	A composite of cardiac death/myocardial infarction	A composite of cardiac death/myocardial infarction	1-year after randomization
Secondary	Cerebrovascular accident	Cerebrovascular accident	1-year after randomization
Secondary	A composite of all-cause death/myocardial infarction/cerebrovascular accident	A composite of all-cause death/myocardial infarction/cerebrovascular accident	1-year after randomization
Secondary	A composite of cardiac death/myocardial infarction/cerebrovascular accident	A composite of cardiac death/myocardial infarction/cerebrovascular accident	1-year after randomization
Secondary	A composite of cardiac death/myocardial infarction/stent thrombosis	A composite of cardiac death/myocardial infarction/stent thrombosis	1-year after randomization
Secondary	Bleeding by BARC types 3 or 5	Bleeding defined by Bleeding Academic Research Consortium (BARC) types 3 or 5	1-year after randomization
Secondary	Bleeding by BARC types 2, 3, or 5	Bleeding defined by BARC types 2, 3 or 5	1-year after randomization
Secondary	Net adverse clinical events	MACE + bleeding by BARC types 3 or 5	1-year after randomization