A Phase 4 interventional study of Intravenous amiodarone(1) and Intravenous amiodarone(2) in Atrial Fibrillation, sponsored by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud · Phase 4, Interventional, and Treatment
Among 46 studies testing amiodarone in Atrial Fibrillation — 12 open to participants now, 12 under way, 3 of them phase 3. Amiodarone · Atrial Fibrillation.
Among the 46 studies testing amiodarone in Atrial Fibrillation, this one is the 35th largest by enrollment, is one of 3 that started in 2008, is one of 20 in phase 4, and was the 24th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 60 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →12 of the 46 studies testing amiodarone in Atrial Fibrillation are open now, in 8 countries. Each count lists the studies.
Amiodarone: first FDA approval 1985 (CORDARONE). What it is approved for, and how studies give it, is on its page →
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →46 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 3 started in 2008.
Median enrollment 124 across the 46 interventional studies. Of the 22 that completed or were terminated, 8 (36%) have results posted.
None of the 46 has an industry lead sponsor. The 10 most frequent:
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud is the lead sponsor of 4 studies on the registry; none are open to participants now.
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud has 1 study filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
2 of the studies testing amiodarone in Atrial Fibrillation that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07487714Tomsk National Research Medical Center of the Russian Academy of SciencesComparative Efficacy of 100-, 200-, & 400-mg Amiodarone in Patients With Paroxysmal AF Depending on Plasma Concentration | 2027-05 |
| NCT06067438OHSU Knight Cancer InstituteAmiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer | 2027-08-30 |
Among the 46 studies testing amiodarone in Atrial Fibrillation, from their registry updates:
Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.
The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.
An open randomized clinical trial was conducted that included 60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of AF.
The patients were randomized in equal proportions and sequentially placed in one of two treatment groups; no patient knew to which group he or she belonged. The first group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 hours was reached. The second group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 hours for up to 72 hours.
All patients were continuously monitored using electrocardiograms, and echocardiograms were performed within 24 hours after the randomized trial began. The exact time of each patient's cardioversion was documented. In addition, general laboratory tests, lipid profiles, thyroid profiles and chest X-rays were obtained for all patients.
A sample size of 30 subjects in each group was calculated. A conversion rate of 60% was assumed, according to literature, and an estimated increase to 90% was assumed for the experimental group to find differences with a power of 0.8 and an alpha error of 0.05.
The primary goal was to obtain was a sinus rhythm conversion rate. The secondary goal was to obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached Intravenous amiodarone (1)
Drug: Intravenous amiodarone(1)
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached Intravenous amiodarone (2)
Drug: Intravenous amiodarone(2)
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached
Also known as: 24 hour amiodarone
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached
Also known as: 72 hour amiodarone
Obtain a continuous sinus rhythm
Monitoring using continuous telemetry.
Time frame: 72 hours
Complication rate of continuous amiodarone intravenous infusion
Obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.
Time frame: 72 hours
Plan to share: Undecided
Ran from Aug 2008 to primary completion in Nov 2009, 15 months.
Of 129 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 81. This study's 15 months is below that.
Counting every sponsor, half of 141 studies reached it within 48 months; a quarter within 27 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Amiodarone
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud