Evidence map›Paper›PMID 36441560›Full record

Trial reportCirculation. Arrhythmia and electrophysiology2022

First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301).

Bruce S Stambler, Francis Plat, Philip T Sager, Silvia Shardonofsky, Douglas Wight, Diane Potvin, A Shekhar Pandey, James E Ip, Benoit Coutu, Blandine Mondésert and 6 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Circulation. Arrhythmia and electrophysiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03464019 (Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 and RAPID Studies), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03464019 phase3terminatednot on this map

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 and RAPID Studies

TypeinterventionalSponsorMilestone Pharmaceuticals Inc.Ran2018 to 2023Enrolled1,097ConditionsParoxysmal Supraventricular TachycardiaArmsEtripamil, Placebo, Etripamil Test Dose
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
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  5. Review
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  8. Practical compendium of antiarrhythmic drugs: a clinical consensus statement of the European Heart Rhythm Association of the European Society of Cardiology.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Review
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  17. Etripamil Nasal Spray: Therapeutic Potential for Treating Paroxysmal Supraventricular Tachycardia.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023
    Review
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  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 14 institutions in 4 countries.

Bruce S StamblerPiedmont Heart Institute, Atlanta, GA (B.S.S.).ORCID 0000-0001-5692-2619
Francis PlatMilestone Pharmaceuticals, Montréal, Québec, Canada (F.P., S.S., D.W.).ORCID 0000-0002-4436-5218
Philip T SagerCardiovascular Research Institute & Department of Medicine, Stanford University, Palo Alto, CA (P.T.S.).ORCID 0000-0002-7055-1786
Silvia ShardonofskyMilestone Pharmaceuticals, Montréal, Québec, Canada (F.P., S.S., D.W.).
Douglas WightMilestone Pharmaceuticals, Montréal, Québec, Canada (F.P., S.S., D.W.).
Diane PotvinExcelsus Statistics, Montréal, Québec' Canada (D.P.).
A Shekhar PandeyCambridge Cardiac Care Centre, Cambridge, Ontario, Canada (A.S.P.).ORCID 0000-0003-2307-2376
James E IpWeill Cornell Medical Center, New York-Presbyterian Hospital, New York, NY (J.E.I.).
Benoit CoutuCentre Hospitalier de l' Université de Montréal Montréal, Québec, Canada (B.C.).
Blandine MondésertMontréal Heart Institute, Université de Montréal, Québec' Canada (B.M.).ORCID 0000-0001-7777-5689
Laurence D SternsVictoria Cardiac Arrhythmia Trials, Inc, Victoria, British Columbia' Canada (L.D.S.).ORCID 0000-0002-3096-2548
Matthew BennettCentre for Cardiovascular Innovation' Division of Cardiology, University of British Columbia, Vancouver, Canada (M.B.).
Jeffrey L AndersonIntermountain Medical Center, Murray, UT (J.L.A.).ORCID 0000-0002-0825-8685
Roger DamleSouth Denver Cardiology Associates, PC, Littleton, CO (R.D.).
Ronald HabermanTop Line Arrhythmia Contractors, LLC, Scottsdale, AZ (R.H.).ORCID 0000-0003-2087-2132
A John CammSt. George's University of London, London, England (A.J.C.).ORCID 0000-0002-2536-2871
Vertex Pharmaceuticals (Canada) · CACambridge Cardiac Care Centre · CACapital Cardiology Associates · USCentre Hospitalier de l’Université de Montréal · CAExcelitas Technologies (Germany) · DEIntermountain Medical Center · USMontreal Heart Institute · CANewYork–Presbyterian Hospital · USPiedmont Atlanta Hospital · USSt George's, University of London · GBTexas Cardiac Arrhythmia · USThe Arrhythmia Institute · USTwitter (United States) · USUniversity of British Columbia · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPharmacologic termination of paroxysmal supraventricular tachycardia (PSVT) often requires medically supervised intervention. Intranasal etripamil, is an investigational fast-acting, nondihydropyridine, L-type calcium channel blocker, designed for unsupervised self-administration to terminate atrioventricular nodal-dependent PSVT. Phase 2 results showed potential safety and efficacy of etripamil in 104 patients with PSVT.

methodsNODE-301, a phase 3, multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of etripamil nasal spray administered, unsupervised in patients with symptomatic sustained PSVT. After a medically supervised etripamil test dose while in sinus rhythm, patients were randomized 2:1 to receive etripamil 70 mg or placebo. When PSVT symptoms developed, patients applied a cardiac monitor and attempted a vagal maneuver; if symptoms persisted, they self-administered blinded treatment. An independent Adjudication Committee reviewed continuous electrocardiogram recordings. The primary efficacy endpoint was termination of adjudicated PSVT within 5 hours after study drug administration.

resultsNODE-301 accrued 156 positively adjudicated PSVT events treated with etripamil (n=107) or placebo (n=49). The hazard ratio for the primary endpoint, time-to-conversion to sinus rhythm during the 5-hour observation period, was 1.086 (95% CI, 0.726-1.623;

conclusionsAlthough the primary 5-hour efficacy endpoint was not met, analyses at earlier time points indicated an etripamil treatment effect in terminating PSVT. Etripamil self-administration during PSVT was safe and well tolerated. These results support continued clinical development of etripamil nasal spray for self-administration during PSVT in a medically unsupervised setting. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03464019.

Indexed as

Tachycardia, ParoxysmalTachycardia, SupraventricularTachycardia, VentricularBenzoatesHumansNasal SpraysBenzoatesetripamilNasal Spraysatrioventricular nodeblood pressurecalciumetripamiltachycardiaverapamil

Identifiers

PMID36441560
PMCPMC9760458
OpenAlexW4310128829

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.