To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home setting; To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers. To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo
The study is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by patients who experience an episode of PSVT in an at-home setting. This is an event-driven study. Enrollment into the study will continue until the adjudication of the 180th positively adjudicated PSVT episode in patients treated with double-blind study drug during the Randomized Treatment Period required for the study's pivotal analysis. After the date of the adjudication of the 180th positively adjudicated PSVT episode, all randomized patients will be unblinded at this timepoint and enter into an approximately 6 months open-label period of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
500
Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Baotou Central Hospital
Baotou, China
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Beijing Anzhen Hospital; Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Chui Yang Liu Hospital Affiliated to Tsinghua University
Time to an adjudicated termination of a positively adjudicated episode of PSVT and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing
The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing.
Time frame: Within 30 minutes of start of study drug dosing.
Time to conversion at time points of 5, 10, 15, 45, and 60 minutes
Time frame: 1 hour after administration of study drug
Time to conversion in patients with the option of repeat administration
Time frame: 1 hour after administration of study drug
The percentage of patients requiring additional medical intervention in emergency department to terminate an episode of PSVT
Time frame: Up to 2 years
Number of participants with relief of specific symptoms (i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting)
Time frame: 1 hour after administration of study drug
Rating of Treatment Satisfaction Questionnaire for Medication (TSQM).
Treatment satisfaction will be analyzed by comparing the Treatment Satisfaction Questionnaire for Medication 9(TSQM-9) score for satisfaction in the 2 treatment groups. The TSQM-9 is composed of 9 questions with responses on a scale of 1 (extremely dissatisfied) to 7 (extremely satisfied). A higher score indicated greater satisfaction with medication.
Time frame: 1 hour after administration of study drug
The percentage of adverse event
Time frame: Up to 2 years
Number of participants with arrhythmias and conduction disorders detected on surface electrocardiogram(ECG) or cardiac monitoring system (CMS) recordings.
Time frame: Up to 2 years
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Beijing, China
Peking Union Medical College Hospital
Beijing, China
The Central Hospital of China Aerospace Corporation
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The Third Xiangya Hospital of Central South University
Changsha, China
...and 43 more locations