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| Name | Class |
|---|---|
| Swiss Heart Foundation | OTHER |
| Fondation Machaon, Switzerland, Genf | UNKNOWN |
| Foundation for Cardiovascular Research Basel | UNKNOWN |
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The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.
Atrial fibrillation is the most common cardiac arrhythmia worldwide and is associated with an increased risk of heart failure, stroke and death. Over the next 40 years the investigators expect another increase in the prevalence of atrial fibrillation with a risk of 1:3 in people over 65 years to develop atrial fibrillation. Electroconversion can occur in patients with atrial fibrillation reestablish sinus rhythm acutely with a controlled electrical shock. Unfortunately it is known however, that there is a short-term recurrence of atrial fibrillation in about 60%. This underlines that our current treatment options are inadequate. There is increasing evidence that inflammation is integral to initiation and maintenance of atrial fibrillation. Therefore, the researchers see inflammation as a possible therapeutic target to reduce the recurrence rate of atrial fibrillation after electroconversion. To test this hypothesis and to help patients, the investigators want to conduct the COLECTRO-AF study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Study participants in the active study arm will receive a daily oral dose of 0.5 mg Colchicine for 3 months without a loading dose. The dose is recommended to be taken in the morning. There is no deviation from the usual treatment intake. |
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| Control Group | Placebo Comparator | Study participants in the placebo group will receive a matched placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 0.5 mg (oral) once daily for 90 days. The chemical name for colchicine is (S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. Colchicine consists of pale yellow scales or powder. It is soluble in water, freely soluble in alcohol, and slightly soluble in ether. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of atrial fibrillation (AF) recurrence | The primary outcome of AF recurrence within 6 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG. | within 6 month after electrocardioversion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of atrial fibrillation (AF) recurrence | The secondary outcome of AF recurrence within 1 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG. | within 1 month after electrocardioversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp Krisai, PD Dr. med. | Contact | +41 61 265 25 25 | Philipp.krisai@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Krisai, PD Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital Baselland (KSBL) | Recruiting | Bruderholz | Basel-Landschaft | 4101 | Switzerland |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| 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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Prospective, randomized, double-blind, placebo-controlled trial.
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A randomization list will be provided by the Clinical Trial Unit Basel to an unblinded person at the sponsor's site. The unblinded person will allocate the randomization numbers. Patients and research staff involved in patient recruitment, data management, outcome adjudication and data analyses will fully be blinded
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| Placebo | Drug | Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group. |
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| Number of atrial fibrillation (AF) recurrence | The secondary outcome of AF recurrence within 3 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG. | within 3 month after electrocardioversion |
| Time to first redo electrocardioversion | Time to first redo electrocardioversion | up to 6 month |
| Use of antiarrhythmic drugs | Assessment of medication intake by study staff Vaughan-Williams classification class 1 and 3 of antiarrhythmic drugs will be documented (1 = sodium channel blockade, 3 = potassium channel blockade) | within 6 month after electrocardioversion |
| Number of survived participants without an unplanned hospital stay | Number of survived participants without an unplanned hospital stay | up to 6 month |
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| University Hospital Bern | Recruiting | Bern | 3010 | Switzerland |
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| Lausanne University Hospital | Recruiting | Lausanne | 1011 | Switzerland |
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| Lucerne Cantonal Hospital | Recruiting | Lucerne | 6000 | Switzerland |
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| Cantonal Hospital Olten | Recruiting | Olten | 4600 | Switzerland |
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| Herzpraxis am Rhein | Recruiting | Rheinfelden | 4310 | Switzerland |
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| Solothurner Spitäler AG | Recruiting | Solothurn | 4500 | Switzerland |
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