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| ID | Type | Description | Link |
|---|---|---|---|
| NIF-14350 | Other Grant/Funding Number | Hamilton Health Science New Investigator Fund |
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The purpose of this study is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).
Atrial fibrillation (AF), the most common cardiac arrhythmia (with a global burden of 33.5 million affected patients in 2010), is responsible for about 20% of ischemic stroke, a major cause of morbidity and mortality. Anticoagulants are very effective in reducing the risk of stroke in AF but on average 10-15% of treated patients still experience a stroke over a 10-year period and in selected elderly populations the risk is even higher. We hypothesize that thrombosis mediated by inflammation might be responsible for the residual risk of stroke, despite anticoagulant therapy and that targeting inflammation has the potential to reduce thrombosis and the risk of stroke in anticoagulated patients with AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Colchicine | Experimental | The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months |
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| Placebo Colchicine | Placebo Comparator | The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 0.6mg twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rates | Number of eligible patients successfully randomized into study per year of study. | Randomization to Month 3 |
| Drop-out rates | Proportion of participants withdrawing from study for any reason | Randomization to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| D-dimer | Mean D-dimer level at baseline and Month 3 for each arm | Randomization to Month 3 |
| hs-CRP | Mean level of hs-CRP at baseline and month 3 for each arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Chan, MD | Population Health Research Institute | Principal Investigator |
| John Eikelboom, MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo Colchicine |
|
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| Randomization to Month 3 |
| Proportion of patients with a clinically significant adverse event | Proportion of patients with side effects such as diarrhoea, myopathy requiring drug cessation | Randomization to Month 3 |
| Drug adherence | Proportion of missing pill to dispensed pill at 6 weeks and month 3 | Randomization to Month 3 |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |