Acute Coronary SyndromePhase 4MACTNCT04949516
Mono Antiplatelet and Colchicine Therapy
A Phase 4 study testing Aspirin and Colchicine in people with Acute Coronary Syndrome and Drug-Eluting Stents, run by Wonkwang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome, Drug-Eluting Stents
- What is being tested?
- Aspirin and Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2021to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful PCI with drug-eluting stent for NSTE-ACS or STEMI
- Provision of written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Drug-Eluting Stents
- Being tested
- Aspirin, Colchicine
- Keywords
- Platelet Aggregation Inhibitors, Colchicine
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Aspirin stop
Aspirin is discontinued the day after drug-eluting stent implantation
ColchicineDrug
Also called Colchicine start
Colchicine is started the day after drug-eluting stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Mono Antiplatelet and Colchicine Therapy | Experimental | Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment Receives: Drug: Aspirin; Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Secondary outcomes (12)
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)
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Target lesion failure
Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All-cause mortality
All-cause mortality
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Cardiac and non-cardiac mortality
Cardiac and non-cardiac mortality
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All myocardial infarction
All myocardial infarction
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - TV-MI and non-TV-MI
TV-MI and non-TV-MI
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All revascularization
All revascularization
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR
ID-TVR, ID-TLR and ID-non-TLR TVR
Measured: 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)
Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Measured: Assessed at hospital stay and 30/90 days after stent implantation
Laboratory outcomes - P2Y12 reaction unit
P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Measured: Assessed at hospital stay
Laboratory outcomes - Percent platelet inhibition
Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Measured: Assessed at hospital stay
Laboratory outcomes - C-reactive protein
C-reactive protein
Measured: Assessed at hospital stay and 30 days after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start15 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Yul Lee, Wonkwang University Hospital
- Investigators
- Seung-Yul Lee, MD, Principal investigator, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949516
- Sponsor's protocol ID
- WKUH 2021-06-004
- Acronym
- MACT
- Status last verified
- Dec 2022
- First submitted
- 17 Jun 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38841588Lee 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.
PubMed 37587591
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study
- ClinicalTrials.gov ID
- NCT04949516
- Acronym / sponsor ID
- MACT / WKUH 2021-06-004
- Conditions
- Acute Coronary Syndrome, Drug-Eluting Stents
- Keywords
- Platelet Aggregation Inhibitors, Colchicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mono Antiplatelet and Colchicine Therapy | Experimental | Drug: Aspirin, Drug: ColchicineAspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Successful PCI with drug-eluting stent for NSTE-ACS or STEMI
- Provision of written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: Aspirin stopAspirin is discontinued the day after drug-eluting stent implantation | Drug | Mono Antiplatelet and Colchicine Therapy |
| ColchicineAlso: Colchicine startColchicine is started the day after drug-eluting stent implantation | Drug | Mono Antiplatelet and Colchicine Therapy |
Primary outcome
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)
12 secondary outcomes
Clinical outcomes - Target vessel failure
Time frame: 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
Clinical outcomes - All-cause mortality
Time frame: 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
Clinical outcomes - All myocardial infarction
Time frame: 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
Clinical outcomes - All revascularization
Time frame: 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
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
Laboratory outcomes - P2Y12 reaction unit
Time frame: Assessed at hospital stay
Laboratory outcomes - Percent platelet inhibition
Time frame: Assessed at hospital stay
Laboratory outcomes - C-reactive protein
Time frame: Assessed at hospital stay and 30 days after stent implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 38841588Lee 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.
- Derived from this study: PubMed 37587591Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Yul Lee, MD principal investigator
Wonkwang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Colchicine in people with Acute Coronary Syndrome and Drug-Eluting Stents, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium) (time frame: Assessed at hospital stay and 30/90 days after stent implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949516, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.