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REPEATED I.V. BOLUSES FLECAINIDE FOR ACUTE ATRIAL FIBRILLATION TERMINATION A SINGLE BLIND RANDOMIZED REGIMEN CONTROLLED TRIAL. - ND

REPEATED I.V. BOLUSES FLECAINIDE FOR ACUTE ATRIAL FIBRILLATION TERMINATION A SINGLE BLIND RANDOMIZED REGIMEN CONTROLLED TRIAL. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000204-33-IT
Enrollment
Unknown
Registered
2007-02-27
Start date
2006-12-29
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ATRIAL FIBRILLATION MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation

Interventions

Pharmaceutical Form: Solution for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-

Sponsors

AZIENDA OSPEDALIERA OSPEDALE DI CIRCOLO A.O. DI RILIEVO REGIONALE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PATIENTS WITH STABLE FOR AL LEAST ONE HOUR ACUTE AF 48 HOURS DURATION AND WITH VENTRICULAR RESPONSE RATE 70 BPM,WHOSE AGE RANGES FROM 18 TO 90 YEARS, PRESENTING TO THE EMERGENCY ROOM OR ARE ADMITTED IN A CARDIOLOGY ON NON-CARDIOLOGY DEPARTMENT. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: CONGESTIVE HEART FAILURE - AMI ACUTE MYOCARDIAL INFARCTION - ARTERIAL HYPOTENSION BLOOD PRESSURE 100 MM OF HG - KNOWN OR CLINICALLY APPARENT MITRAL STENOSIS - HISTORY OF MYCARDIAL ISCHEMIA - ELECTROLYTE IMBALANCES - SIGNIFICANT HEPATIC OR RENAL DISEASE LIVER ENZYMES ALT OR AST AT LEAST TWICE NORMAL UPPER LIMITS OR CREATININE GREATER THAN TWO MG/DL - ACIDOSIS - SUSPECT OF PULMONARY EMBOLISM - PREGNANCY - PREVIOUS BIFASCICULAR BLOCK LBBB OR RBBB LPH IF MEAN HEART 120 BPM.

Design outcomes

Primary

MeasureTime frame
Main Objective: TO DETERMINE WHETHER THE REPEATED I.V. BOLUSES METHOD GROUP 1 IS MORE EFFECTIVE IN GETTING A NORMAL SINUS RHYTHM SR COMPARED WITH A STANDARD QUICK INFUSION GROUP 2 WITHIN 20 MINUTES FROM THE BEGINNING OF TREATMENT PRIMARY ENDPOINT .;Secondary Objective: 1 MORE EFFICACIOUSNESS OF BOLUSES METHOD IN GETTING SR WITHIN 2 HOURS; 2 LESS SIDE EFFECTS WITH THE BOLUSES METHOD WITHIN 2 HOURS.;Primary end point(s): TO DETERMINE WHETHER THE REPEATED I.V. BOLUSES METHOD GROUP 1 IS MORE EFFECTIVE IN GETTING A NORMAL SINUS RHYTHM SR COMPARED WITH A STANDARD QUICK INFUSION GROUP 2 WITHIN 20 MINUTES FROM THE BEGINNING OF TREATMENT PRIMARY ENDPOINT .—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026