A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study of AP30663 Given Intravenously for Cardioversion in Patients with Atrial Fibrillation

Acesion Pharma ApS0 sites108 target enrollmentApril 1, 2019

ConditionsAtrial Fibrillation MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Acesion Pharma ApS
Enrollment: 108
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 1, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Acesion Pharma ApS

Eligibility Criteria

Inclusion Criteria

•To be eligible for study entry, patients must satisfy all of the following criteria:
•1\. Provision of written informed consent.
•2\. Clinical indication for cardioversion of atrial fibrillation.
•3\. Current episode of symptomatic atrial fibrillation lasting between 3 h and 7 days inclusive at randomisation.
•4\. Adequate anticoagulation according to international and/or national guidelines.
•5\. Body weight 50 to 110 kg inclusive (with clothes, without shoes).
•6\. Male patients and postmenopausal women aged 18 to 80 years inclusive.
•\- Male patients who are sexually active must agree to abstain from sexual activity or be willing to use a double\-barrier method of birth control (i.e. any double combination of male or female condom with spermicidal gel, diaphragm, sponge or cervical cap with spermicidal gel) if they become sexually active from the time of consent and for 90 days after the infusion day.
•\- Post\-menopausal women are defined as being \>12 months after last menstrual period.
•\- Women can also be included if permanently sterilised since \=6 weeks (i.e. documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy). Breastfeeding women are excluded.

Exclusion Criteria

•1\. Significant clinical illness or surgical procedure within 4 weeks preceding the screening visit.
•2\. Present renal dysfunction (estimated glomerular filtration rate \[eGFR] \<30 mL/min), hepatic dysfunction (alanine aminotransferase \[ALT] or aspartate aminotransferase \[AST] \>3 × upper limit of normal), or uncontrolled hyperthyroidism or hypothyroidism.
•3\. History of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease or other significant disease, as judged by the investigator.
•4\. Any cardioversion attempt of AF or atrial flutter within 1 week preceding randomisation.
•5\. Prior failed attempt (no conversion) of pharmacological or DC cardioversion of previous or current AF episode.
•6\. Failure to find a large antecubital (or equivalent) vein for the infusion.
•7\. Any of the following events, or any other significant cardiovascular event as judged by the investigator, during the last 6 weeks before randomisation: myocardial infarction, unstable angina pectoris or other signs of myocardial ischaemia, stroke or transient ischaemic attack, myocardial revascularisation (percutaneous coronary intervention \[PCI], coronary artery bypass graft \[CABG]), or other revascularisation procedure.
•8\. Haemodynamically unstable condition as judged by the investigator; systolic blood pressure (BP) \<90 mm Hg or \>180 mm Hg, or diastolic BP \>105 mm Hg at randomisation.
•9\. Blood haemoglobin \<100 g/L at screening.
•10\. Congestive heart failure New York Heart Association class III or IV. Left ventricular ejection fraction \<40% on echocardiography, or other clinically significant abnormality on the echocardiogram (not older than 6 months) as judged by the investigator.