Phase 2
Completed N=18
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
Source: ClinicalTrials.gov NCT01396226 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Left Atrial Effective Refractory Period — 2.5; 5; 2.5; 10.8 msec
Summary
Medical Products Agency
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Atrial Effective Refractory Period |
2.7; 5; 2.7; 10.8 | — |
| SECONDARY Ventricular Effective Refractory Period |
-0.9; 1.7 | — |
| SECONDARY Paced QT Interval |
-1.0; 6.3 | — |
| SECONDARY Atrio-ventricular Effective Refractory Period |
-16.9; 1.7; -19.4; 3.2 | — |
| SECONDARY PA Interval |
1.7; 9.3 | — |
| SECONDARY AH Interval |
0; -2.2 | — |
| SECONDARY HV Interval |
-3.5; 3.5 | — |
| SECONDARY PR Interval |
-5.1; 19.3; -8.0; 4.3 | — |
| SECONDARY QRS Duration |
-1.2; -0.3; -2.5; -2.5 | — |
| SECONDARY RR Interval |
21.3; 57.2; -11.5; -8.3 | — |
Eligibility Criteria
Inclusion Criteria
- male or postmenopausal female, aged 20 to 80 years inclusive,
- clinical indication for catheter ablation of atrial flutter,
- history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
- sinus rhythm at randomisation,
- adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,
Exclusion Criteria
- cardioversion within 14 days before randomisation,
- history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
- QTcF >450 ms or 30 s) monomorphic ventricular tachycardia.
Data sourced from ClinicalTrials.gov (NCT01396226). 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.