P2Y12 Inhibitor Monotherapy Versus Extended DAPT in Patients Treated With Bioresorbable Scaffold

NCT03119012 | Terminated Phase 4 DMC

• 1 other identifier: CHOICEII16453143
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the efficacy and safety of P2Y12 inhibitor monotherapy versus extended dual antiplatelet therapy (DAPT) following 12-month of DAPT in patients undergoing percutaneous coronary intervention (PCI) with bioresorbable scaffold (BRS)

Conditions

Coronary Artery Disease; Stents; Atherosclerosis

Keywords

Bioresorbable scaffold; Dual antiplatelet therapy; P2Y12 receptor inhibitor; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• A composite of death, myocardial infarction, and cerebrovascular events

  defined as MACCE

  36 months after the index procedure

Secondary Outcomes (9)

• All-cause death

  36 months after the index procedure

• Cardiac death

  36 months after the index procedure

• Myocardial infarction

  36 months after the index procedure

• Cerebrovascular accident

  36 months after the index procedure

• target lesion revascularization (TLR)

  36 months after the index procedure

Study Arms (2)

P2Y12 receptor inhibitor monotherapy arm

ACTIVE COMPARATOR

In patients who do not occur a MACCE until 12-month after BRS implantation, P2Y12 receptor inhibitor monotherapy arm will be received clopidogrel 75mg qd or ticagrelor 60mg bid during follow-up period (24 months after randomization).

Drug: Clopidogrel; Drug: Ticagrelor

Extended DAPT arm

ACTIVE COMPARATOR

In patients who do not occur a MACCE until 12-month after BRS implantation, Extended DAPT arm will be received aspirin 100mg qd plus P2Y12 receptor inhibitor (clopidogrel 75mg qd or ticagrelor 60mg bid) during follow-up period (24 months after randomization).

Drug: Clopidogrel; Drug: Ticagrelor; Drug: Aspirin

Interventions

Clopidogrel DRUG

75mg/day

Also known as: Clopidogrel or its generic

Extended DAPT arm; P2Y12 receptor inhibitor monotherapy arm

Ticagrelor DRUG

120mg/day

Also known as: Brillinta

Extended DAPT arm; P2Y12 receptor inhibitor monotherapy arm

Aspirin DRUG

100mg/day

Also known as: Any commercially available aspirin

Extended DAPT arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 19 years of age.
• Patients who do not occur a major adverse cardiac and cerebral events (MACCE) at 12-month after BRS implantation
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving P2Y12 antagonist monotherapy or aspirin plus P2Y12 antagonist and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

You may not qualify if:

• Active bleeding
• 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).

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Clopidogrel; Ticagrelor; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, open label, two-arm, randomized controlled trial

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 18, 2017
• Study Start: April 19, 2017
• Primary Completion: December 18, 2017
• Study Completion: February 9, 2018
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)