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Phase 3 Completed N=360 Randomized Prevention

Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

Source: ClinicalTrials.gov NCT03021343 ↗
Enrolled (actual)
360
Serious AEs
15.0%
Results posted
Dec 2017
Primary outcomePrimary: The Number of Participants With Atrial Fibrillation — 26; 37 Participants
◆ Published Evidence
Established
68citations · ~7 / year
Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial.
American heart journal · 2016 · High-confidence link

Summary

This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

Linked Publications

  • Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial.
    American heart journal · 2016 · 68 citations · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
The Number of Participants With Atrial Fibrillation
26; 37
PRIMARY
The Number of Participants With Colchicine Side Effects
55; 14

Eligibility Criteria

Inclusion Criteria

  • All consecutive adult patients undergoing elective cardiac surgery

Exclusion Criteria

  • Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission
  • 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
  • Significant gastrointestinal disease
  • Pregnant and lactating women
  • Known hypersensitivity to colchicine
  • Current treatment with colchicine for any indications
  • Emergency surgery
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03021343) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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