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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03015831 |
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Date of registration:
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04/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Low Dose ColchiciNe on the InciDence of POAF
END-AFLD |
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Scientific title:
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Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients |
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Date of first enrolment:
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October 2, 2017 |
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Target sample size:
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254 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03015831 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Ramzi Tabbalat, MD, FACC |
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Address:
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Telephone:
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Email:
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Affiliation:
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JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients aged 18 years or above undergoing elective cardiac surgery.
- Sinus rhythm and no previous AF
- Agreed to sign informed consent.
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colchicine Adverse Reaction
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Atrial Fibrillation
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Cardiac Surgery
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Intervention(s)
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Drug: Colchicine
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Drug: Placebo Oral Tablet
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Primary Outcome(s)
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Atrial fibrillation
[Time Frame: Through study completion, an average of 1 week]
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Secondary Outcome(s)
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Side effects of colchicine
[Time Frame: Through study completion, an average of 1 week]
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Secondary ID(s)
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JordanCCG
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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