The Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT) NODE 301 (RAPID; ClinicalTrials.gov identifier: NCT03464019) study is under way to determine whether etripamil self-administered by patients is superior to placebo for terminating PSVT in a medically unsupervised setting, researchers reported in the American Heart Journal.
The RAPID study was designed after the NODE-301 study did not meet its prespecified primary endpoint of PSVT conversion in 5 hours after a single dose of etripamil 70 mg. Analysis at earlier time points, however, had shown a treatment effect for the first 30 minutes.
The primary objective of RAPID is to determine whether a dosing regimen that includes an initial 70-mg dose of etripamil and a second dose 10 minutes later if symptoms persist is superior to a similar dosing regimen of placebo in terminating PSVT within 30 minutes of administration in a medically unsupervised setting. The secondary objective is to assess the safety of etripamil when self-administered by patients without medical supervision.
Etripamil is a fast-acting, nondihydropyridine, L-type calcium channel blocker that is formulated for intranasal administration with a nasal spray delivery device to provide rapid onset of action (<5 minutes).
The phase 3, multicenter, randomized, double-blinded, placebo-controlled RAPID trial includes newly enrolled patients, as well as those from NODE-301 who had not received the study drug before the cutoff point for the part 1 analysis on January 15, 2020. Eligible participants are aged 18 years or older, with electrocardiographically documented PSVT and a history of sustained PSVT.
Routine monthly follow-up visits are scheduled to assess for adverse events and changes in concomitant medications, confirm ongoing eligibility, and provide retraining for PSVT procedures.
The study’s findings will be presented at scientific and medical conferences and in peer-reviewed publications and will be used in drug applications made to regulatory agencies, including the US Food and Drug Administration.
The researchers noted that the lack of a prespecified time after PSVT initiation when the study drug must be taken could affect the conversion rate and time to conversion in each group, although patients are encouraged to self-administer early.
“A successful RAPID pivotal study outcome carries the promise for etripamil nasal spray to change the treatment paradigm for the outpatient treatment of PSVT,” the investigators wrote.
Disclosure: This research is funded by Milestone Pharmaceuticals. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Plat F, Stambler BS, Sager PT, et al. 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. Published online June 18, 2022. doi: 10.1016/j.ahj.2022.06.005