Mono Antiplatelet and Colchicine Therapy (MACT)

December 31, 2022 updated by: Seung-Yul Lee, Wonkwang University Hospital

Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mono Antiplatelet and Colchicine Therapy
Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment
Drug: Aspirin
Aspirin is discontinued the day after drug-eluting stent implantation
Other Names:
  • Aspirin stop
Drug: Colchicine
Colchicine is started the day after drug-eluting stent implantation
Other Names:
  • Colchicine start

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Assessed at hospital stay and 30/90 days after stent implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical outcomes - Target vessel failure
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
Composite time-to-first event rate of cardiac death, target vessel-myocardial infarction (TV-MI), or ischemia driven-target vessel revascularization (ID-TVR)
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Target lesion failure
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All-cause mortality
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
All-cause mortality
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Cardiac and non-cardiac mortality
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
Cardiac and non-cardiac mortality
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All myocardial infarction
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
All myocardial infarction
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - TV-MI and non-TV-MI
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
TV-MI and non-TV-MI
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All revascularization
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
All revascularization
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR
Time Frame: Assessed at hospital stay and 30/90 days after stent implantation
ID-TVR, ID-TLR and ID-non-TLR TVR
Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - 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
Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Assessed at hospital stay and 30/90 days after stent implantation
Laboratory outcomes - P2Y12 reaction unit
Time Frame: Assessed at hospital stay
P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Assessed at hospital stay
Laboratory outcomes - Percent platelet inhibition
Time Frame: Assessed at hospital stay
Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Assessed at hospital stay
Laboratory outcomes - C-reactive protein
Time Frame: Assessed at hospital stay and 30 days after stent implantation
C-reactive protein
Assessed at hospital stay and 30 days after stent implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wonkwang University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Yul Lee, MD, Wonkwang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WKUH 2021-06-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings