MACT: Mono Antiplatelet and Colchicine Therapy

• Sponsor: Wonkwang University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04949516
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18.5
• Patients Per Site Per Month: 10.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Drug-Eluting Stents	Drug: Aspirin; Drug: Colchicine	Phase 4

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

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study
• Actual Study Start Date: Jun 15, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium) [Assessed at hospital stay and 30/90 days after stent implantation]

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

Secondary Outcome Measures

1. Clinical outcomes - Target vessel failure [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)

2. Clinical outcomes - Target lesion failure [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)

3. Clinical outcomes - All-cause mortality [Assessed at hospital stay and 30/90 days after stent implantation]

   All-cause mortality

4. Clinical outcomes - Cardiac and non-cardiac mortality [Assessed at hospital stay and 30/90 days after stent implantation]

   Cardiac and non-cardiac mortality

5. Clinical outcomes - All myocardial infarction [Assessed at hospital stay and 30/90 days after stent implantation]

   All myocardial infarction

6. Clinical outcomes - TV-MI and non-TV-MI [Assessed at hospital stay and 30/90 days after stent implantation]

   TV-MI and non-TV-MI

7. Clinical outcomes - All revascularization [Assessed at hospital stay and 30/90 days after stent implantation]

   All revascularization

8. Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR [Assessed at hospital stay and 30/90 days after stent implantation]

   ID-TVR, ID-TLR and ID-non-TLR TVR

9. Clinical outcomes - 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]

   Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)

10. Laboratory outcomes - P2Y12 reaction unit [Assessed at hospital stay]

    P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer

11. Laboratory outcomes - Percent platelet inhibition [Assessed at hospital stay]

    Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer

12. Laboratory outcomes - C-reactive protein [Assessed at hospital stay and 30 days after stent implantation]

    C-reactive protein

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wonkwang University Hospital	Iksan		Korea, Republic of	54538

Sponsors and Collaborators

• Wonkwang University Hospital

Investigators

• Principal Investigator: Seung-Yul Lee, MD, Wonkwang University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Yul Lee, Associate Professor, Wonkwang University Hospital
• ClinicalTrials.gov Identifier: NCT04949516
• Other Study ID Numbers: WKUH 2021-06-004
• First Posted: Jul 2, 2021
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seung-Yul Lee, Associate Professor, Wonkwang University Hospital: Platelet Aggregation Inhibitors; Colchicine
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome; Aspirin; Colchicine

Study Results

No Results Posted as of Jul 13, 2022