InflammationNCT03735134
Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
A study testing Colchicine Loading Dose in people with Inflammation and Myocardial Infarction, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammation, Myocardial Infarction
- What is being tested?
- Colchicine Loading Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2018to Jul 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized with troponin negative events and scheduled for elective PCI
Who cannot join
- Significant renal dysfunction
- Significant liver dysfunction
- Severe left ventricular dysfunction
- Severe low weight
- Chronic colchicine treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hille Yaffe Medical Center
Hadera, 38100
Rami Abu Fanne, MD, PhD, 972-503573694, ramia@hadassah.org.il
About this study
The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.
- Conditions
- Inflammation, Myocardial Infarction
- Being tested
- Colchicine Loading Dose, Standard of care treatment prior to elective PCI
- Medical subject headings
- Inflammation, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine Loading DoseDrug
Two milligrams of colchicine will be administrated in addition to the standard of care treatment
Standard of care treatment prior to elective PCIDrug
All medications normally given to patients prior to elective PCI
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment Receives: Drug: Standard of care treatment prior to elective PCI |
| Early colchicine loading dose | Active comparator | Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose 12-24 hours before PCI Receives: Drug: Colchicine Loading Dose |
| Late colchicine loading dose | Active comparator | Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose one hour prior to PCI Receives: Drug: Colchicine Loading Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of PPMI post elective PCI
Occurrence of PPMI post elective PCI and its relation to defensin levels
Measured: 24 hours post PCI
Secondary outcomes (2)
Traditional inflammatory markers
Determination of traditional inflammatory markers including c-reactive protein, white blood cells and interleukin-6
Measured: 24 hours post PCI
Major adverse cardiovascular events
Determining the occurrence of major adverse cardiovascular events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735134
- Sponsor's protocol ID
- HYMC-99-18
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
- ClinicalTrials.gov ID
- NCT03735134
- Acronym / sponsor ID
- HYMC-99-18
- Conditions
- Inflammation, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 8 Nov 2018 (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.
The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Standard of care treatment prior to elective PCIStable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment |
| Early colchicine loading dose | Active comparator | Drug: Colchicine Loading DoseStable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose 12-24 hours before PCI |
| Late colchicine loading dose | Active comparator | Drug: Colchicine Loading DoseStable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose one hour prior to PCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients hospitalized with troponin negative events and scheduled for elective PCI
Key exclusion criteria (5 listed)
- Significant renal dysfunction
- Significant liver dysfunction
- Severe left ventricular dysfunction
- Severe low weight
- Chronic colchicine treatment
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 Loading DoseTwo milligrams of colchicine will be administrated in addition to the standard of care treatment | Drug | Early colchicine loading dose, Late colchicine loading dose |
| Standard of care treatment prior to elective PCIAll medications normally given to patients prior to elective PCI | Drug | Control Group |
Primary outcome
Occurrence of PPMI post elective PCI
Time frame: 24 hours post PCI
Occurrence of PPMI post elective PCI and its relation to defensin levels
2 secondary outcomes
Traditional inflammatory markers
Time frame: 24 hours post PCI
Major adverse cardiovascular events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colchicine Loading Dose in people with Inflammation and Myocardial Infarction, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 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 8 Nov 2018. 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 Israel. 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.
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 Rami Abu Fanne, MD, PhD (972-50-3573694, ramia@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of PPMI post elective PCI (time frame: 24 hours post PCI). 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 8 Nov 2018.