Reperfusion Injury, MyocardialPhase 3NCT05734612

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

A Phase 3 study testing Colchicine in people with Reperfusion Injury, Myocardial, run by Universitas Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Reperfusion Injury, Myocardial
What is being tested?: Colchicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteIndonesia
Study dates: 4 Dec 2022to 31 Mar 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430

Other trials in Indonesia

About this study

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

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.

Conditions: Reperfusion Injury, Myocardial
Being tested: Colchicine, Placebo (lactose)
Keywords: Myocardial reperfusion injury, Colchicine
Medical subject headings: Myocardial Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ColchicineDrug
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.
Placebo (lactose)Drug
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.

Study groups in NCT05734612
Study group	Role	What they receive
Colchicine	Experimental	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. Receives: Drug: Colchicine
Placebo	Placebo comparator	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. Receives: Drug: Placebo (lactose)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Up to 3 days after primary percutaneous coronary intervention

Secondary outcomes (4)

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
Measured: 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention
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
Measured: 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention
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
Measured: 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention
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
Measured: 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 202231 Mar 2023

First posted21 Feb 2023
Study start4 Dec 2022
Primary completion31 Mar 2023 (estimated)
Study completion31 Mar 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Reperfusion Injury, MyocardialStudies of the same condition, open and under way.
More trials run by Universitas IndonesiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05734612
Sponsor's protocol ID: 22-09-1046
Status last verified: Feb 2023
First submitted: 11 Jan 2023
Last updated: 21 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Deftereos S, Giannopoulos G, Angelidis C, Alexopoulos N, Filippatos G, Papoutsidakis N, Sianos G, Goudevenos J, Alexopoulos D, Pyrgakis V, Cleman MW, Manolis AS, Tousoulis D, Lekakis J. Anti-Inflammatory Treatment With Colchicine in Acute Myocardial Infarction: A Pilot Study. Circulation. 2015 Oct 13;132(15):1395-403. doi: 10.1161/CIRCULATIONAHA.115.017611. Epub 2015 Aug 11.
PubMed 26265659
Akodad M, Lattuca B, Nagot N, Georgescu V, Buisson M, Cristol JP, Leclercq F, Macia JC, Gervasoni R, Cung TT, Cade S, Cransac F, Labour J, Dupuy AM, Roubille F. COLIN trial: Value of colchicine in the treatment of patients with acute myocardial infarction and inflammatory response. Arch Cardiovasc Dis. 2017 Jun-Jul;110(6-7):395-402. doi: 10.1016/j.acvd.2016.10.004. Epub 2017 Jan 3.
PubMed 28065445
Mewton N, Roubille F, Bresson D, Prieur C, Bouleti C, Bochaton T, Ivanes F, Dubreuil O, Biere L, Hayek A, Derimay F, Akodad M, Alos B, Haider L, El Jonhy N, Daw R, De Bourguignon C, Dhelens C, Finet G, Bonnefoy-Cudraz E, Bidaux G, Boutitie F, Maucort-Boulch D, Croisille P, Rioufol G, Prunier F, Angoulvant D. Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction. Circulation. 2021 Sep 14;144(11):859-869. doi: 10.1161/CIRCULATIONAHA.121.056177. Epub 2021 Aug 23.
PubMed 34420373
Vaidya K, Martinez G, Patel S. The Role of Colchicine in Acute Coronary Syndromes. Clin Ther. 2019 Jan;41(1):11-20. doi: 10.1016/j.clinthera.2018.07.023. Epub 2018 Sep 2.
PubMed 30185392
Raju NC, Yi Q, Nidorf M, Fagel ND, Hiralal R, Eikelboom JW. Effect of colchicine compared with placebo on high sensitivity C-reactive protein in patients with acute coronary syndrome or acute stroke: a pilot randomized controlled trial. J Thromb Thrombolysis. 2012 Jan;33(1):88-94. doi: 10.1007/s11239-011-0637-y.
PubMed 21918905
Robertson S, Martinez GJ, Payet CA, Barraclough JY, Celermajer DS, Bursill C, Patel S. Colchicine therapy in acute coronary syndrome patients acts on caspase-1 to suppress NLRP3 inflammasome monocyte activation. Clin Sci (Lond). 2016 Jul 1;130(14):1237-46. doi: 10.1042/CS20160090. Epub 2016 Apr 21.
PubMed 27129183
Vaidya K, Arnott C, Martinez GJ, Ng B, McCormack S, Sullivan DR, Celermajer DS, Patel S. Colchicine Therapy and Plaque Stabilization in Patients With Acute Coronary Syndrome: A CT Coronary Angiography Study. JACC Cardiovasc Imaging. 2018 Feb;11(2 Pt 2):305-316. doi: 10.1016/j.jcmg.2017.08.013. Epub 2017 Oct 18.
PubMed 29055633
Martinez GJ, Robertson S, Barraclough J, Xia Q, Mallat Z, Bursill C, Celermajer DS, Patel S. Colchicine Acutely Suppresses Local Cardiac Production of Inflammatory Cytokines in Patients With an Acute Coronary Syndrome. J Am Heart Assoc. 2015 Aug 24;4(8):e002128. doi: 10.1161/JAHA.115.002128.
PubMed 26304941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
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Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
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RecruitingObservational study
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
Myocardial Ischemia, Heart Defects, Congenital
Active, not recruitingPhase 2
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
Reperfusion Injury, Myocardial, Myocardial Infarction
Not yet recruitingPhase 2
Combined Antioxidant Therapy for Acute Myocardial Infarction
Acute Myocardial Infarction (AMI), ST Elevation (STEMI) Myocardial Infarction

All Reperfusion Injury, Myocardial trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05734612
Acronym / sponsor ID: 22-09-1046
Conditions: Reperfusion Injury, Myocardial
Keywords: Myocardial reperfusion injury, Colchicine
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Study start: 4 Dec 2022 (actual)
Primary completion: 31 Mar 2023 (estimated)
Study completion: 31 Mar 2023 (estimated)
First posted: 21 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Colchicine	Experimental	Drug: ColchicinePatients 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.
Placebo	Placebo comparator	Drug: Placebo (lactose)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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ColchicinePatients 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.	Drug	Colchicine
Placebo (lactose)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.	Drug	Placebo

Primary outcome

The Rate of Myocardial Reperfusion Injury
Time frame: Up to 3 days after primary percutaneous coronary intervention
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

4 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
Background: PubMed 26265659Deftereos S, Giannopoulos G, Angelidis C, Alexopoulos N, Filippatos G, Papoutsidakis N, Sianos G, Goudevenos J, Alexopoulos D, Pyrgakis V, Cleman MW, Manolis AS, Tousoulis D, Lekakis J. Anti-Inflammatory Treatment With Colchicine in Acute Myocardial Infarction: A Pilot Study. Circulation. 2015 Oct 13;132(15):1395-403. doi: 10.1161/CIRCULATIONAHA.115.017611. Epub 2015 Aug 11.
Background: PubMed 28065445Akodad M, Lattuca B, Nagot N, Georgescu V, Buisson M, Cristol JP, Leclercq F, Macia JC, Gervasoni R, Cung TT, Cade S, Cransac F, Labour J, Dupuy AM, Roubille F. COLIN trial: Value of colchicine in the treatment of patients with acute myocardial infarction and inflammatory response. Arch Cardiovasc Dis. 2017 Jun-Jul;110(6-7):395-402. doi: 10.1016/j.acvd.2016.10.004. Epub 2017 Jan 3.
Background: PubMed 34420373Mewton N, Roubille F, Bresson D, Prieur C, Bouleti C, Bochaton T, Ivanes F, Dubreuil O, Biere L, Hayek A, Derimay F, Akodad M, Alos B, Haider L, El Jonhy N, Daw R, De Bourguignon C, Dhelens C, Finet G, Bonnefoy-Cudraz E, Bidaux G, Boutitie F, Maucort-Boulch D, Croisille P, Rioufol G, Prunier F, Angoulvant D. Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction. Circulation. 2021 Sep 14;144(11):859-869. doi: 10.1161/CIRCULATIONAHA.121.056177. Epub 2021 Aug 23.
Background: PubMed 30185392Vaidya K, Martinez G, Patel S. The Role of Colchicine in Acute Coronary Syndromes. Clin Ther. 2019 Jan;41(1):11-20. doi: 10.1016/j.clinthera.2018.07.023. Epub 2018 Sep 2.
Background: PubMed 21918905Raju NC, Yi Q, Nidorf M, Fagel ND, Hiralal R, Eikelboom JW. Effect of colchicine compared with placebo on high sensitivity C-reactive protein in patients with acute coronary syndrome or acute stroke: a pilot randomized controlled trial. J Thromb Thrombolysis. 2012 Jan;33(1):88-94. doi: 10.1007/s11239-011-0637-y.
Background: PubMed 27129183Robertson S, Martinez GJ, Payet CA, Barraclough JY, Celermajer DS, Bursill C, Patel S. Colchicine therapy in acute coronary syndrome patients acts on caspase-1 to suppress NLRP3 inflammasome monocyte activation. Clin Sci (Lond). 2016 Jul 1;130(14):1237-46. doi: 10.1042/CS20160090. Epub 2016 Apr 21.
Background: PubMed 29055633Vaidya K, Arnott C, Martinez GJ, Ng B, McCormack S, Sullivan DR, Celermajer DS, Patel S. Colchicine Therapy and Plaque Stabilization in Patients With Acute Coronary Syndrome: A CT Coronary Angiography Study. JACC Cardiovasc Imaging. 2018 Feb;11(2 Pt 2):305-316. doi: 10.1016/j.jcmg.2017.08.013. Epub 2017 Oct 18.
Results publication: PubMed 26304941Martinez GJ, Robertson S, Barraclough J, Xia Q, Mallat Z, Bursill C, Celermajer DS, Patel S. Colchicine Acutely Suppresses Local Cardiac Production of Inflammatory Cytokines in Patients With an Acute Coronary Syndrome. J Am Heart Assoc. 2015 Aug 24;4(8):e002128. doi: 10.1161/JAHA.115.002128.
Individual participant dataSharing planned: No

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Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Birry Karim principal investigator

Fakultas Kedokteran Universitas Indonesia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine in people with Reperfusion Injury, Myocardial, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Rate of Myocardial Reperfusion Injury (time frame: Up to 3 days after primary percutaneous coronary intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05734612, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.