Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543082
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
MACT Mono Antiplatelet and Colchicine Therapy Prospective Multicenter Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Outcomes of Colchicine Therapy Following Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome the MACT Mono Antiplatelet and Colchicine Therapy Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MACT II
Brief Summary:
The previous Mono Antiplatelet and Colchicine Therapy MACT pilot study NCT04949516 demonstrated that it was feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after percutaneous coronary intervention PCI in addition to potent P2Y12 inhibitors in patients with acute coronary syndrome ACS However the efficacy and safety of MACT have not yet been investigated The goal of this clinical trial is to evaluate the clinical outcomes of ticagrelor P2Y12 inhibitor monotherapy combined with colchicine immediately after PCI in patients with ACS The main questions it aims to answer are
What is the frequency of the composite endpoint of cardiovascular death nonfatal spontaneous myocardial infarction nonfatal ischemic stroke unplanned hospitalization leading to urgent revascularization and major bleeding at 12 months post-intervention
What is the frequency of stent thrombosis at 12 months post-intervention
For pre-specified analyses researchers will compare MACT to less than 1 month 3-month and 12-month dual antiplatelet therapy individual patient data from the T-PASS NCT03797651 and TICO NCT02494895 trials to determine if MACT is effective in treating ACS
Participants will
Take low-dose colchicine in addition to ticagrelor maintenance therapy discontinuing aspirin the day after PCI
Take a high-sensitivity C-reactive protein hs-CRP test 1 month after PCI
Discontinue colchicine if the hs-CRP level is less than 2 mgL or continue colchicine if it is not
Visit the clinic for check-ups at 1 3 6 9 and 12 months after PCI
What is the frequency of the composite endpoint of cardiovascular death nonfatal spontaneous myocardial infarction nonfatal ischemic stroke unplanned hospitalization leading to urgent revascularization and major bleeding at 12 months post-intervention
What is the frequency of stent thrombosis at 12 months post-intervention
For pre-specified analyses researchers will compare MACT to less than 1 month 3-month and 12-month dual antiplatelet therapy individual patient data from the T-PASS NCT03797651 and TICO NCT02494895 trials to determine if MACT is effective in treating ACS
Participants will
Take low-dose colchicine in addition to ticagrelor maintenance therapy discontinuing aspirin the day after PCI
Take a high-sensitivity C-reactive protein hs-CRP test 1 month after PCI
Discontinue colchicine if the hs-CRP level is less than 2 mgL or continue colchicine if it is not
Visit the clinic for check-ups at 1 3 6 9 and 12 months after PCI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None