Acute Coronary SyndromePhase 2/3COOLNCT00754819
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
A Phase 2/3 study testing Colchicine in people with Acute Coronary Syndrome, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a diagnosis of acute coronary syndrome who are > 18 years old and who do not have any contraindication to colchicine.
Who cannot join
- Contraindication to colchicine including any of the following:
- hypersensitivity to colchicine
- severe renal, hepatic or gastrointestinal disorder
- blood dyscrasias (myelodysplasia cytopenias etc)
- Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
- Known severe liver disease and/or elevated transaminases > 1.5x the upper limit of normal
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- Estimated GFR < 50 ml/min
- Pregnant or lactating women or women not protected by a reliable contraception method
- Current treatment with colchicine at enrollment
- Active infection or systemic inflammation eg active rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial
The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Colchicine, Placebo
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
1mg once daily
PlaceboDrug
1 capsule daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Colchicine 1mg daily oral Receives: Drug: Colchicine |
| 2 | Placebo comparator | Placebo 1 capsule daily oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of low dose colchicine on hs-CRP.
Measured: 30 days
Secondary outcomes (1)
To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of 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 posted18 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- John Eikelboom, FRACP FRCPA, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754819
- Sponsor's protocol ID
- COL0001
- Acronym
- COOL
- Status last verified
- Oct 2009
- First submitted
- 16 Sep 2008
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial
- ClinicalTrials.gov ID
- NCT00754819
- Acronym / sponsor ID
- COOL / COL0001
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- 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 purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ColchicineColchicine 1mg daily oral |
| 2 | Placebo comparator | Drug: PlaceboPlacebo 1 capsule daily oral |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a diagnosis of acute coronary syndrome who are > 18 years old and who do not have any contraindication to colchicine.
Key exclusion criteria (10 listed)
- Contraindication to colchicine including any of the following:
- Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
- Known severe liver disease and/or elevated transaminases > 1.5x the upper limit of normal
- Estimated GFR < 50 ml/min
- Pregnant or lactating women or women not protected by a reliable contraception method
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 |
|---|---|---|
| Colchicine1mg once daily | Drug | 1 |
| Placebo1 capsule daily | Drug | 2 |
Primary outcome
To determine the effect of low dose colchicine on hs-CRP.
Time frame: 30 days
1 secondary outcome
To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events
Time frame: 30 days
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 8 Oct 2009.
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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.
John Eikelboom, FRACP FRCPA study director
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colchicine in people with Acute Coronary Syndrome, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 10 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 8 Oct 2009. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the effect of low dose colchicine on hs-CRP. (time frame: 30 days). 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 Oct 2009.