Atrial FibrillationPhase 3END-AFLDNCT03015831
Effect of Low Dose ColchiciNe on the InciDence of POAF
A Phase 3 study testing Colchicine in people with Atrial Fibrillation and Cardiac Surgery, run by Jordan Collaborating Cardiology Group at 3 sites in Jordan.
Trial summary
The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Cardiac Surgery, Colchicine Adverse Reaction
- 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
- 254 participants
- Where
- 3 sitesJordan
- Study dates
- 2 Oct 2017to 1 May 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18 years or above undergoing elective cardiac surgery.
- Sinus rhythm and no previous AF
- Agreed to sign informed consent.
Who cannot join
- Known severe liver disease or current transaminases >1.5 times the upper normal limit
- Current serum creatinine >2.5 mg/dL
- Known myopathy or elevated baseline preoperative creatine kinase
- Known blood dyscrasias or significant gastrointestinal disease
- Pregnant and lactating women
- Known hypersensitivity to colchicine
- Current treatment with colchicine for any indications
- Emergency surgery
Trial locations and contacts
3 sites in 1 country.
Jordan3 sites
Istishari Hospital
Amman
Jordan Hospital
Amman
Khalidi Hospital & Medical Center
Amman
About this study
Official title: Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients
The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.
Read the detailed description
AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge.
The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects
- Being tested
- Colchicine, Placebo Oral Tablet
- Keywords
- Atrial fibrillation, Cardiac surgery, Colchicine
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Colcrys, Mitigare
Colchicine will be given to open heart surgery patients
Placebo Oral TabletDrug
Also called Placebo
Placebo Oral Tablet will be given to open heart surgery patients according to randomization
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge Receives: Drug: Colchicine |
| Placebo Oral Tablet | Placebo comparator | Identical tablet (placebo) administered in a similar way as that in the active comparator arm Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
AF documented by EKG
Measured: Through study completion, an average of 1 week
Secondary outcomes (1)
Side effects of colchicine
Gastrointestinal side effects
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start2 Oct 2017
- Primary completion1 Apr 2019
- Study completion1 May 2019
Why it stopped: Statistical analysis of interim data showed no advantage of colchicine
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 Atrial FibrillationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramzi Tabbalat, MD, FACC, Principal investigator, JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015831
- Sponsor's protocol ID
- JordanCCG
- Acronym
- END-AFLD
- Status last verified
- Apr 2020
- First submitted
- 4 Jan 2017
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our Group's website will share data. Researchgate will share data. Eventual results will be announced to medical community through local presentations, and international congresses and publications.
Publications
Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.
PubMed 32720823
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients
- ClinicalTrials.gov ID
- NCT03015831
- Acronym / sponsor ID
- END-AFLD / JordanCCG
- Keywords
- Atrial fibrillation, Cardiac surgery, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Statistical analysis of interim data showed no advantage of colchicine
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 10 Jan 2017 (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 prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.
Detailed description
AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge.
The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: ColchicineIntervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletIdentical tablet (placebo) administered in a similar way as that in the active comparator arm |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients aged 18 years or above undergoing elective cardiac surgery.
- Sinus rhythm and no previous AF
- Agreed to sign informed consent.
Key exclusion criteria (8 listed)
- Known severe liver disease or current transaminases >1.5 times the upper normal limit
- Current serum creatinine >2.5 mg/dL
- Known myopathy or elevated baseline preoperative creatine kinase
- Known blood dyscrasias or significant gastrointestinal disease
- Pregnant and lactating women
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 |
|---|---|---|
| ColchicineAlso: Colcrys, MitigareColchicine will be given to open heart surgery patients | Drug | Colchicine |
| Placebo Oral TabletAlso: PlaceboPlacebo Oral Tablet will be given to open heart surgery patients according to randomization | Drug | Placebo Oral Tablet |
Primary outcome
Atrial fibrillation
Time frame: Through study completion, an average of 1 week
AF documented by EKG
1 secondary outcome
Side effects of colchicine
Time frame: Through study completion, an average of 1 week
Results and safety
The study was stopped early (reason given: Statistical analysis of interim data showed no advantage of colchicine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Derived from this study: PubMed 32720823Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.
- Individual participant dataSharing planned: Yes. Our Group's website will share data. Researchgate will share data. Eventual results will be announced to medical community through local presentations, and international congresses and publications.
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
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.
Ramzi Tabbalat, MD, FACC principal investigator
JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan
3 sites 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 Atrial Fibrillation and Cardiac Surgery, run by Jordan Collaborating Cardiology Group at 3 sites in Jordan.
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 8 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: stopped early, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Jordan. 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?
The study was stopped early (reason given: Statistical analysis of interim data showed no advantage of colchicine). 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?
Atrial fibrillation (time frame: Through study completion, an average of 1 week). 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 NCT03015831, 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 1 May 2020.