Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).

Summary

This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting. NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. Part 2 (also referred as the RAPID study) included participants that did not receive the randomized study drug in Part 1 and newly enrolled participants until the 180th positively adjudicated PSVT episode in Part 2. The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension).

Timeline

Start

2018-06-18

Primary completion

2023-01-20

Completion

2023-01-20

Outcome

Outcome not reported

Stopped: “The closure of the event-driven study was terminated due to the total sample size was reached.”

Publications

• Stambler BS, Camm AJ, Alings M, Dorian P, Heidbuchel H, Houtgraaf J, Kowey PR, Merino JL, Mondesert B, Piccini JP, Pokorney SD, Sager PT, Verma A, Wharton JM, Bharucha DB, Plat F, Shardonofsky S, Chen M, Ip JE; RAPID Investigators. Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial. Lancet. 2023 Jul 8;402(10396):118-128. doi: 10.1016/S0140-6736(23)00776-6. Epub 2023 Jun 15.
• Stambler BS, Plat F, Sager PT, Shardonofsky S, Wight D, Potvin D, Pandey AS, Ip JE, Coutu B, Mondesert B, Sterns LD, Bennett M, Anderson JL, Damle R, Haberman R, Camm AJ. First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301). Circ Arrhythm Electrophysiol. 2022 Dec;15(12):e010915. doi: 10.1161/CIRCEP.122.010915. Epub 2022 Nov 28.
• Stambler BS, Plat F, Sager PT, Lubkov V, Shardonofsky S, Wight D, Chen M, Camm AJ. Rationale for and design of a multicenter, placebo-controlled, phase 3 study to assess efficacy and safety of intranasal etripamil for the conversion of paroxysmal supraventricular tachycardia. Am Heart J. 2022 Nov;253:20-29. doi: 10.1016/j.ahj.2022.06.005. Epub 2022 Jun 18.

Drugs

Indications