Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES

Coronary Artery Disease Clinical Trial

— SMART-CHOICE  

Official title:

Comparison Between P2Y12 Antagonist MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary Drug-Eluting Stents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02079194
• Other study ID #: SMC 2014-01-161
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 18, 2014
• Est. completion date: July 7, 2020

Study information

• Verified date: January 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with DES.

Description:

This trial is a prospective, randomized, multi-center, open label, noninferiority trial. Patients undergoing PCI with DES will be eligible. After successful PCI with DES, all eligible patients will be randomized either to clopidogrel monotherapy or to aspirin plus P2Y12 antagonist following 3-month of DAPT.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must be at least 20 years of age.

• Subject is able to 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 successful PCI

Exclusion Criteria:

• Hemodynamic instability or cardiogenic shock

• Active bleeding

• Known hypersensitivity or contraindication to study medications

• 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 <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).

• DES implantation within 12 months before index procedure

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• P2Y12 antagonist monotherapy

• aspirin plus P2Y12 antagonist

Locations

Country	Name	City	State
Korea, Republic of	Cardiac and Vascular Center; Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of death, myocardial infarction, or cerebrovascular events	12 months after the index procedure	1 year
Secondary	All cause Death		1 years
Secondary	cardiac death		1 years
Secondary	Myocardial infarction (MI)		1 years
Secondary	Cerebrovascular accident (CVA)		1 years
Secondary	Target lesion revascularization (TLR)		1 years
Secondary	Target vessel revascularization (TVR)		1 years
Secondary	Any revascularization		1 years
Secondary	Stent thrombosis: definite or probable stent thrombosis by ARC definition		1 years
Secondary	BARC bleeding =2		1 years
Secondary	BARC bleeding =3		1 years
Secondary	Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization		1 years