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The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury

Primary Purpose

Reperfusion Injury, Myocardial

Status
Enrolling by invitation
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Colchicine
Placebo (lactose)
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reperfusion Injury, Myocardial focused on measuring Myocardial reperfusion injury, Colchicine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with ST-elevation myocardial infarction based on clinical symptoms, signs, and electrocardiography who undergo primary percutaneous coronary intervention Patients aged 18 - 80 years old Exclusion Criteria: Patients with malignancy Patients with allergic reaction to colchicine Stroke within the last 3 months Severe infection (sepsis) Chronic kidney disease with eGFR of <30mL/min/1.73m2

Sites / Locations

  • Fakultas Kedokteran Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days.

Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.

Outcomes

Primary Outcome Measures

The Rate of Myocardial Reperfusion Injury
The rate of hypotension, acute heart failure, arrhythmias, persistent chest pain, or microvascular obstruction up to 3 days after primary percutaneous coronary intervention after primary percutaneous coronary intervention

Secondary Outcome Measures

Activation of NLRP3 in peripheral blood vein measured in counts
Activation of NLRP3 in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention measured in counts
Concentration of ASC in peripheral blood vein in ng/ml
Concentration of ASC in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in ng/ml
Concentration of caspase in peripheral blood vein in pg/ml
Concentration of caspase in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in pg/ml
Concentration of troponin in peripheral blood vein in ng/L
Concentration of troponin in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in ng/L

Full Information

First Posted
January 11, 2023
Last Updated
February 8, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05734612
Brief Title
The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury
Official Title
The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury in Patients With ST-Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: Study on NLRP3, ASC, Caspase, and Troponin
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 4, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to investigate the role of colchicine in reducing the rate of myocardial reperfusion injury in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention. The main questions it aims to answer are: Does colchicine reduce the rate of myocardial reperfusion injury ? Does colchicine reduce the concentration of markers of myocardial reperfusion injury (NLRP3, ASC, caspase, and troponin) ? Participants will Be grouped into intervention group and control group blindly. Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days. Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days. Undergo peripheral blood vein examination before primary percutaneous coronary intervention, after primary percutaneous coronary intervention, 24 hour after primary percutaneous coronary intervention, and 48 hour after primary percutaneous coronary intervention. Researchers will compare intervention group and control group to see if colchicine reduces the rate of myocardial reperfusion injury and reduces the concentration of markers of myocardial reperfusion injury (NLRP3, ASC, caspase, and troponin) in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury, Myocardial
Keywords
Myocardial reperfusion injury, Colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be grouped into two groups which are intervention group and control group. Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days. Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Colchicine and placebo (lactose) will be packed in capsules with the same appearance by the pharmacist. The pharmacist will code the capsules containing colchicine or the capsules containing placebo into group A or group B without informing the participant, care provider, investigator, and outcome assessor regarding the content of each group of capsules. Participant, care provider, investigator, and outcome assessor do not know the content of the capsules given to the participants.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Experimental
Arm Description
Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo (lactose)
Intervention Description
Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.
Primary Outcome Measure Information:
Title
The Rate of Myocardial Reperfusion Injury
Description
The rate of hypotension, acute heart failure, arrhythmias, persistent chest pain, or microvascular obstruction up to 3 days after primary percutaneous coronary intervention after primary percutaneous coronary intervention
Time Frame
Up to 3 days after primary percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
Activation of NLRP3 in peripheral blood vein measured in counts
Description
Activation of NLRP3 in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention measured in counts
Time Frame
30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention
Title
Concentration of ASC in peripheral blood vein in ng/ml
Description
Concentration of ASC in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in ng/ml
Time Frame
30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention
Title
Concentration of caspase in peripheral blood vein in pg/ml
Description
Concentration of caspase in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in pg/ml
Time Frame
30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention
Title
Concentration of troponin in peripheral blood vein in ng/L
Description
Concentration of troponin in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in ng/L
Time Frame
30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with ST-elevation myocardial infarction based on clinical symptoms, signs, and electrocardiography who undergo primary percutaneous coronary intervention Patients aged 18 - 80 years old Exclusion Criteria: Patients with malignancy Patients with allergic reaction to colchicine Stroke within the last 3 months Severe infection (sepsis) Chronic kidney disease with eGFR of <30mL/min/1.73m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birry Karim
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fakultas Kedokteran Universitas Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Results Reference
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The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury

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