Acute Coronary SyndromePhase 3NCT06054100
The Effect of Colchicine on Inflammation in ACS Patients
A Phase 3 study testing Colchicine Tablets in people with Acute Coronary Syndrome and STEMI, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, STEMI
- What is being tested?
- Colchicine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 20 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female
- >18 yrs
- STEMI patients who were successfully treated with PCI.
Who cannot join
- Pregnant or breast-feeding women or women of childbearing potential.
- Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
- Known hypersensitivity to colchicine or current chronic treatment with colchicine.
- Severe renal failure (estimated creatinine clearance <30ml/min) or hepatic failure (Child Pugh score B or C )
- Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
- Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
Read the detailed description
This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.
- Conditions
- Acute Coronary Syndrome, STEMI
- Being tested
- Colchicine Tablets
- Keywords
- Colchicine, Inflammation, ACS, STEMI, Atherosclerosis
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine TabletsDrug
Also called Colchicine
Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Colchicine group | Experimental | Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months Receives: Drug: Colchicine Tablets |
| STEMI standard treatment group | No intervention | Control group, STEMI standard treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of colchicine therapy on sST2 levels in ACS patients
sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months
Measured: 3 months
Secondary outcomes (4)
Effect of colchicine therapy on occurrence of ischemic events in ACS patients
Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period
Measured: 3 months
Change in left ventricular ejection fraction
Effect of colchicine therapy on left ventricular ejection fraction percentage (%)
Measured: 3 months
Change in serum levels of IL-1beta
Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L
Measured: 3 months
Lipid profile parameters and TG/HDL-C ratio
Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Feb 2020
- Primary completion15 Feb 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan ahmed, Ain Shams University
- Investigators
- Marwa A Ahmed, Phd, Study director, Faculty of Pharmacy, Ain Shams UniversityLamia El Wakeel, Phd, Study director, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054100
- Sponsor's protocol ID
- 2511
- Status last verified
- Sep 2023
- First submitted
- 22 Feb 2020
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hassanain HA, El Wakeel LM, Khorshid H, Ahmed MA. Colchicine effect on biomarkers of cardiac remodelling and atherosclerosis in ST-elevation myocardial infarction: A randomized controlled trial. Br J Clin Pharmacol. 2025 Feb;91(2):427-438. doi: 10.1111/bcp.16270. Epub 2024 Oct 2.
PubMed 39359014
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT06054100
- Acronym / sponsor ID
- 2511
- Conditions
- Acute Coronary Syndrome, STEMI
- Keywords
- Colchicine, Inflammation, ACS, STEMI, Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 26 Sep 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.
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
Detailed description
This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine group | Experimental | Drug: Colchicine TabletsColchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months |
| STEMI standard treatment group | No intervention | –Control group, STEMI standard treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female
- >18 yrs
- STEMI patients who were successfully treated with PCI.
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding women or women of childbearing potential.
- Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
- Known hypersensitivity to colchicine or current chronic treatment with colchicine.
- Severe renal failure (estimated creatinine clearance <30ml/min) or hepatic failure (Child Pugh score B or C )
- Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
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 |
|---|---|---|
| Colchicine TabletsAlso: ColchicineColchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months | Drug | Colchicine group |
Primary outcome
Effect of colchicine therapy on sST2 levels in ACS patients
Time frame: 3 months
sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months
4 secondary outcomes
Effect of colchicine therapy on occurrence of ischemic events in ACS patients
Time frame: 3 months
Change in left ventricular ejection fraction
Time frame: 3 months
Change in serum levels of IL-1beta
Time frame: 3 months
Lipid profile parameters and TG/HDL-C ratio
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 39359014Hassanain HA, El Wakeel LM, Khorshid H, Ahmed MA. Colchicine effect on biomarkers of cardiac remodelling and atherosclerosis in ST-elevation myocardial infarction: A randomized controlled trial. Br J Clin Pharmacol. 2025 Feb;91(2):427-438. doi: 10.1111/bcp.16270. Epub 2024 Oct 2.
- Individual participant dataSharing planned: No
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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.
Marwa A Ahmed, Phd study director
Faculty of Pharmacy, Ain Shams University
Lamia El Wakeel, Phd study director
Faculty of Pharmacy, Ain Shams University
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 Tablets in people with Acute Coronary Syndrome and STEMI, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Sep 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of colchicine therapy on sST2 levels in ACS patients (time frame: 3 months). 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 NCT06054100, which also lists 1 linked publication.
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 26 Sep 2023.