Phase 2
Completed N=171
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Source: ClinicalTrials.gov NCT00915356 ↗Enrolled (actual)
171
Serious AEs
—
Results posted
Feb 2012
Primary outcomePrimary: Dose-response Relationship for QTcF Interval of AZD1305 — 461; 486; 490; 482 ms
Summary
This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-response Relationship for QTcF Interval of AZD1305 |
461; 486; 490; 482; 440 | — |
| PRIMARY Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR) |
7.7; 17.8; 37.8; 50.0; 0.0 | — |
| SECONDARY Wide QRS Tachycardias |
4; 15; 16; 2; 7 | — |
| SECONDARY Heart Rhythm. Number of Participants With Early Relapse Into AF. |
1; 1; 2; 0; 1 | — |
| SECONDARY Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion |
23; 34; 36; 10; 33 | — |
| SECONDARY Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion. |
14; 23; 25; 7; 22 | — |
| SECONDARY Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval. |
— | — |
| SECONDARY Maximal Observed Plasma Concentration of AZD1305 |
0.521; 1.28; 1.39; 1.69 | — |
| SECONDARY Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days |
0; 2; 5; 1; 0 | — |
| SECONDARY Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days. |
0; 4; 6; 2; 0 | — |
| SECONDARY Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months |
2; 2; 6; 3; 0 | — |
| SECONDARY Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion |
100.0; 95.5; 91.1; 100.0; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm
- Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation
- Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines
Exclusion Criteria
- Potassium level below 3.8 mmol/L measured in serum or plasma
- QTcF interval >440 ms
Data sourced from ClinicalTrials.gov (NCT00915356). 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.