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Mono Antiplatelet and Colchicine Therapy (MACT)

Primary Purpose

Acute Coronary Syndrome, Drug-Eluting Stents

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin
Colchicine
Sponsored by
Wonkwang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Platelet Aggregation Inhibitors, Colchicine

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Wonkwang University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mono Antiplatelet and Colchicine Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical outcomes - Target vessel failure
Composite time-to-first event rate of cardiac death, target vessel-myocardial infarction (TV-MI), or ischemia driven-target vessel revascularization (ID-TVR)
Clinical outcomes - Target lesion failure
Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)
Clinical outcomes - All-cause mortality
All-cause mortality
Clinical outcomes - Cardiac and non-cardiac mortality
Cardiac and non-cardiac mortality
Clinical outcomes - All myocardial infarction
All myocardial infarction
Clinical outcomes - TV-MI and non-TV-MI
TV-MI and non-TV-MI
Clinical outcomes - All revascularization
All revascularization
Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR
ID-TVR, ID-TLR and ID-non-TLR TVR
Clinical outcomes - Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Laboratory outcomes - P2Y12 reaction unit
P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Laboratory outcomes - Percent platelet inhibition
Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Laboratory outcomes - C-reactive protein
C-reactive protein

Full Information

First Posted
June 17, 2021
Last Updated
December 31, 2022
Sponsor
Wonkwang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04949516
Brief Title
Mono Antiplatelet and Colchicine Therapy
Acronym
MACT
Official Title
Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University 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
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.
Detailed Description
After successful drug-eluting stent implantation for acute coronary syndrome, screening for study subject enrollment is performed. For those who submitted written informed consent, aspirin is stopped the day after the intervention, and colchicine 0.6mg once daily is started. The P2Y12 inhibitor, prasugrel or ticagrelor, for single antiplatelet therapy remains. For the duration of hospital stay, platelet reactivity using VerifyNow test and C-reactive protein are measured. Aspirin may be restarted at the discretion of the investigator based on results of the platelet function test. C-reactive protein is remeasured 30 days after the intervention. Clinical follow-up is performed 30 days and 90 days after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Drug-Eluting Stents
Keywords
Platelet Aggregation Inhibitors, Colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mono Antiplatelet and Colchicine Therapy
Arm Type
Experimental
Arm Description
Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin stop
Intervention Description
Aspirin is discontinued the day after drug-eluting stent implantation
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Colchicine start
Intervention Description
Colchicine is started the day after drug-eluting stent implantation
Primary Outcome Measure Information:
Title
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Description
Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Secondary Outcome Measure Information:
Title
Clinical outcomes - Target vessel failure
Description
Composite time-to-first event rate of cardiac death, target vessel-myocardial infarction (TV-MI), or ischemia driven-target vessel revascularization (ID-TVR)
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - Target lesion failure
Description
Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - All-cause mortality
Description
All-cause mortality
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - Cardiac and non-cardiac mortality
Description
Cardiac and non-cardiac mortality
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - All myocardial infarction
Description
All myocardial infarction
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - TV-MI and non-TV-MI
Description
TV-MI and non-TV-MI
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - All revascularization
Description
All revascularization
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR
Description
ID-TVR, ID-TLR and ID-non-TLR TVR
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Clinical outcomes - Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Description
Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Time Frame
Assessed at hospital stay and 30/90 days after stent implantation
Title
Laboratory outcomes - P2Y12 reaction unit
Description
P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Time Frame
Assessed at hospital stay
Title
Laboratory outcomes - Percent platelet inhibition
Description
Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Time Frame
Assessed at hospital stay
Title
Laboratory outcomes - C-reactive protein
Description
C-reactive protein
Time Frame
Assessed at hospital stay and 30 days after stent implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Successful PCI with drug-eluting stent for NSTE-ACS or STEMI Provision of written informed consent Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Yul Lee, MD
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonkwang University Hospital
City
Iksan
ZIP/Postal Code
54538
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Mono Antiplatelet and Colchicine Therapy

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