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OpenTrials
Completed

NCT Number: NCT04949516

Mono Antiplatelet and Colchicine Therapy

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.

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wonkwang University Hospital

Iksan, 54538, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Aspirin is discontinued the day after drug-eluting stent implantation

Other names: Aspirin stop

Colchicine

Drug

Colchicine is started the day after drug-eluting stent implantation

Other names: Colchicine start

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. Clinical outcomes - All-cause mortality

    Time frame: Assessed at hospital stay and 30/90 days after stent implantation

    All-cause mortality

  4. 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

  5. Clinical outcomes - All myocardial infarction

    Time frame: Assessed at hospital stay and 30/90 days after stent implantation

    All myocardial infarction

  6. 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

  7. Clinical outcomes - All revascularization

    Time frame: 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

    Time frame: 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)

    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)

  10. Laboratory outcomes - P2Y12 reaction unit

    Time frame: Assessed at hospital stay

    P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer

  11. Laboratory outcomes - Percent platelet inhibition

    Time frame: Assessed at hospital stay

    Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer

  12. Laboratory outcomes - C-reactive protein

    Time frame: Assessed at hospital stay and 30 days after stent implantation

    C-reactive protein

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

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

Acronym: MACT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2021
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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