STEMIPhase 4NCT06020300
Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
A Phase 4 study testing Oral Colchicine 0.6 mg and Oral Pyridoxine 10 mg in people with STEMI, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI
- What is being tested?
- Oral Colchicine 0.6 mg and Oral Pyridoxine 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- 28 Jul 2023to 31 May 2024
- Phase
- Phase 4
- 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
- Age between 18 years to 80 years old
- STEMI within 24 hours of admission to Pusat Perubatan UKM \& undergoing revascularization therapy (percutaneous coronary intervention) during admission
- STEMI is diagnosed when there is:
- ST elevation of ≥1 mm in 2 contiguous leads or
- a new onset LBBB in the resting ECG
- in a patient with ischaemic type chest pains of > 30 minutes and
- accompanied by a rise and fall in cardiac biomarkers (CPG MALAYSIA STEMI 2019, 4th Edition)
Who cannot join
- Pre-existing severe heart failure with left ventricular ejection fraction less than 35%
- Clinically unstable (Intubated or double inotropic support)
- Refuse or not suitable for cardiac revascularization therapy
- Anaemia induced Angina (Hb < 9 g/dL)
- Ongoing sepsis requiring antibiotic
- Ongoing diarrhea (Loose stool 3 times or more per day - stool consistency Bristol chart type 6 \& 7)
Show all 20Show fewer
- Active Covid-19 Infection (< 7 days for Category 1-3, < 10 days for category 4-5)
- Stroke within previous 3 months
- Coronary bypass surgery either within the previous 3 years or planned
- Active malignancy or treated malignancy within 7 years
- Active Inflammatory bowel disease on treatment
- Active Neuromuscular disease on treatment
- Chronic kidney disease (CKD stage 4 - eGFR < 30 mL/min/1.73 m2)
- Severe hepatic disease (ALT > 3X upper limit normal, Bilirubin > 2X upper limit normal)
- Active drug or alcohol abuse on therapy
- On long term or recent systemic glucocorticoid therapy within 3 months
- Pregnancy or breastfeeding
- Known sensitivity to colchicine or multivitamin tablet
- Pre-existing indication for colchicine therapy (Gout, Familial Mediterranean fever, etc)
- Patients on oral medications that may interact with colchicine (Clarithromycin, Ketoconazole, Voriconazole, Fluconazole, Itraconazole, Cyclosporine, Ritonavir)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Nationa University of Malaysia
Kuala Lumpur, Kuala Lumpur, 56000
CHITHAMBARAM SETHURAMAN, MBBS, 03-9145 ext. 8251, chithambaramsethuraman@gmail.com
HAMAT HAMDI, MBBchBAO, 03-9145 ext. 8251, hamathamdi@gmail.com
About this study
To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)
Read the detailed description
Colchicine is a cheap and potent anti-inflammatory. We believe anti-inflammatory is able to reduce inflammation in coronary arteries and heart muscle post ST elevation myocardial infarction which may benefit in short and long term outcome in patients. The short term outcome is measured using serum troponin and long term outcome is assessed with transthoracic echocardiogram and major adverse cardiac events.
- Conditions
- STEMI
- Being tested
- Oral Colchicine 0.6 mg, Oral Pyridoxine 10 mg
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Colchicine 0.6 mgDrug
Also called GOUTNOR 0.6 mg Tablet
Anti-Inflammatory Effects
Oral Pyridoxine 10 mgDrug
Also called MSA Pyridoxine HCI 10 mg Tablet
Colchicine look alike placebo
| Study group | Role | What they receive |
|---|---|---|
| Colchicine Post ST Elevation Myocardial Infarction (STEMI) | Experimental | 32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days Receives: Drug: Oral Colchicine 0.6 mg |
| Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI) | Placebo comparator | Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days Receives: Drug: Oral Pyridoxine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Inflammatory Effect of Colchicine
Serum Troponin I change from arrival to discharge
Measured: 3-7 days
Major Adverse Cardiac Events (MACE)
Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident
Measured: 3 months
Secondary outcomes (2)
Trans thoracic Echo cardiogram parameters
Left ventricular ejection fraction (biplane mode) measured in %, left ventricular volume measured in milliliters, left atrial volume measured in milliliters, E/A ratio, E/e ' ratio
Measured: 3 months
Safety of colchicine
Number of Participants with medication side effects
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start28 Jul 2023
- Primary completion29 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine \& placebo group with 1:1 ratio
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HAMAT HAMDI, MBBchBAO, Principal investigator, Head of Cardiology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020300
- Sponsor's protocol ID
- FF-2023-191
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
- ClinicalTrials.gov ID
- NCT06020300
- Acronym / sponsor ID
- FF-2023-191
- Conditions
- STEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 31 Aug 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.
To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)
Detailed description
Colchicine is a cheap and potent anti-inflammatory. We believe anti-inflammatory is able to reduce inflammation in coronary arteries and heart muscle post ST elevation myocardial infarction which may benefit in short and long term outcome in patients. The short term outcome is measured using serum troponin and long term outcome is assessed with transthoracic echocardiogram and major adverse cardiac events.
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
- Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine \& placebo group with 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Colchicine Post ST Elevation Myocardial Infarction (STEMI) | Experimental | Drug: Oral Colchicine 0.6 mg32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days |
| Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI) | Placebo comparator | Drug: Oral Pyridoxine 10 mgAnother 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 years to 80 years old
- STEMI within 24 hours of admission to Pusat Perubatan UKM \& undergoing revascularization therapy (percutaneous coronary intervention) during admission
- ST elevation of ≥1 mm in 2 contiguous leads or
- a new onset LBBB in the resting ECG
- in a patient with ischaemic type chest pains of > 30 minutes and
Key exclusion criteria (20 listed)
- Pre-existing severe heart failure with left ventricular ejection fraction less than 35%
- Clinically unstable (Intubated or double inotropic support)
- Refuse or not suitable for cardiac revascularization therapy
- Anaemia induced Angina (Hb < 9 g/dL)
- Ongoing sepsis requiring antibiotic
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 |
|---|---|---|
| Oral Colchicine 0.6 mgAlso: GOUTNOR 0.6 mg TabletAnti-Inflammatory Effects | Drug | Colchicine Post ST Elevation Myocardial Infarction (STEMI) |
| Oral Pyridoxine 10 mgAlso: MSA Pyridoxine HCI 10 mg TabletColchicine look alike placebo | Drug | Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI) |
Primary outcome
Anti-Inflammatory Effect of Colchicine
Time frame: 3-7 days
Serum Troponin I change from arrival to discharge
Major Adverse Cardiac Events (MACE)
Time frame: 3 months
Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident
2 secondary outcomes
Trans thoracic Echo cardiogram parameters
Time frame: 3 months
Safety of colchicine
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for STEMI
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
HAMAT HAMDI, MBBchBAO principal investigator
Head of Cardiology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Colchicine 0.6 mg and Oral Pyridoxine 10 mg in people with STEMI, run by National University of Malaysia at 1 site in Malaysia.
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 7 inclusion and 20 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 31 Aug 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 Malaysia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact CHITHAMBARAM SETHURAMAN, MBBS (03-9145 ext. 8251, chithambaramsethuraman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Inflammatory Effect of Colchicine (time frame: 3-7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2023.