NCT04949516

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of aspirin-free, P2Y12 inhibitor single antiplatelet and colchicine treatment in patients with acute coronary syndrome treated with drug-eluting stents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

June 17, 2021

Last Update Submit

December 31, 2022

Conditions

Acute Coronary SyndromeDrug-Eluting Stents

Keywords

Platelet Aggregation InhibitorsColchicine

Outcome Measures

Primary Outcomes (1)

  • Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)

    Definite, probable, and possible stent thrombosis (Academic Research Consortium)

    Assessed at hospital stay and 30/90 days after stent implantation

Secondary Outcomes (12)

  • Clinical outcomes - Target vessel failure

    Assessed at hospital stay and 30/90 days after stent implantation

  • Clinical outcomes - Target lesion failure

    Assessed at hospital stay and 30/90 days after stent implantation

  • Clinical outcomes - All-cause mortality

    Assessed at hospital stay and 30/90 days after stent implantation

  • Clinical outcomes - Cardiac and non-cardiac mortality

    Assessed at hospital stay and 30/90 days after stent implantation

  • Clinical outcomes - All myocardial infarction

    Assessed at hospital stay and 30/90 days after stent implantation

  • +7 more secondary outcomes

Study Arms (1)

Mono Antiplatelet and Colchicine Therapy

EXPERIMENTAL

Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment

Drug: AspirinDrug: Colchicine

Interventions

AspirinDRUG

Aspirin is discontinued the day after drug-eluting stent implantation

Also known as: Aspirin stop
Mono Antiplatelet and Colchicine Therapy
ColchicineDRUG

Colchicine is started the day after drug-eluting stent implantation

Also known as: Colchicine start
Mono Antiplatelet and Colchicine Therapy

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successful PCI with drug-eluting stent for NSTE-ACS or STEMI
  • Provision of written informed consent

You may not qualify if:

  • Cardiac arrest or cardiogenic shock
  • Age \<19 or \>90 years old
  • Severe liver impairment
  • Severe renal impairment (eGFR \<30 mL/min/1.73 m2)
  • Atrial fibrillation requiring anticoagulation therapy
  • Intolerance of prasugrel, ticagrelor, or colchicine
  • History of intracranial hemorrhage
  • Active bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonkwang University Hospital

Iksan, 54538, South Korea

Location

Related Publications (2)

  • Lee SY, Cho JY, Gorog DA, Angiolillo DJ, Yun KH, Ahn JH, Koh JS, Park Y, Hwang SJ, Hwang JY, Kim JW, Jang Y, Jeong YH. Inflammation and platelet reactivity during adjunctive colchicine versus aspirin in patients with acute coronary syndrome treated with potent P2Y12 inhibitor. Front Med (Lausanne). 2024 Apr 19;11:1349577. doi: 10.3389/fmed.2024.1349577. eCollection 2024.

    PMID: 38841588DERIVED

  • Lee SY, Jeong YH, Yun KH, Cho JY, Gorog DA, Angiolillo DJ, Kim JW, Jang Y. P2Y12 Inhibitor Monotherapy Combined With Colchicine Following PCI in ACS Patients: The MACT Pilot Study. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1845-1855. doi: 10.1016/j.jcin.2023.05.035.

    PMID: 37587591DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

AspirinColchicine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAlkaloidsHeterocyclic Compounds

Study Officials

  • Seung-Yul Lee, MD

    Wonkwang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 2, 2021

Study Start

June 15, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 4, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)