Mono Antiplatelet and Colchicine Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-12-31

Brief Summary

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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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Detailed Description

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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

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Acute Coronary Syndrome Drug-Eluting Stents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mono Antiplatelet and Colchicine Therapy

Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Aspirin is discontinued the day after drug-eluting stent implantation

Colchicine

Intervention Type DRUG

Colchicine is started the day after drug-eluting stent implantation

Interventions

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Aspirin

Aspirin is discontinued the day after drug-eluting stent implantation

Intervention Type DRUG

Colchicine

Colchicine is started the day after drug-eluting stent implantation

Intervention Type DRUG

Other Intervention Names

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Aspirin stop Colchicine start

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No