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

NCT ID: NCT03464019

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1097 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2023-01-20

Brief 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).

Detailed Description

NODE-301 was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by participants who experienced an episode of PSVT in an at-home setting. Each episode was documented by an ambulatory Cardiac Monitoring System (CMS) that was placed on the chest by the participants or caregiver when symptoms begin and recorded at least 5 hours of continuous electrocardiogram (ECG).

This was an event-driven study. The study comprised of three parts: Parts 1, 2, and 3.

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 (January 15th, 2020). Participants were randomized to etripamil 70 mg or placebo in a 2:1 ratio. Participants had a Test Dose Randomization Visit where they received 70 mg etripamil in sinus rhythm and a Treatment Period during which they could administer the randomized study drug during a perceived episode of PSVT.

Part 2 (also referred as the RAPID study) included participants that did not use the randomized study drug to treat a perceived episode of PSVT before the Part 1 data cutoff and newly enrolled participants. Before randomization in the RAPID study, all participants received a Test Dose of etripamil consisting of an initial dose of etripamil 70 mg followed by a second dose of etripamil 70 mg 10 minutes later to evaluate tolerability and to train participants on the study procedures. After a successful Test Dose, participants in Part 2 were randomized to etripamil or placebo in a 1:1 ratio. When experiencing a PSVT episode, participants were instructed to administer a first dose of randomized study drug (70 mg etripamil or placebo) followed 10 minutes later, if PSVT symptoms persisted, by a second dose of study drug (70 mg etripamil or placebo). After having administered the randomized study drug for a perceived episode of PSVT, participants could enter an open-label period during which they had the possibility to treat a second episode of PSVT with open-label etripamil (70 mg etripamil with optional second dose of 70 mg etripamil).

Part 2 continued until the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID was conducted) (July 20th 2022). 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). The design of Parts 2 and 3 were the same and therefore their results are combined in this publication.

NODE-301 study comprised 6 arms:

• 2 arms consisting of participants enrolled in Part 1 that treated a perceived episode of PSVT with randomized study drug (etripamil NS 70 mg or placebo) in a 2:1 ratio.
• 1 arm consisting of participants that only received the Test Dose in Part 1.
• 2 arms consisting of participants enrolled in Parts 2 and 3 that treated a perceived episode of PSVT with randomized study drug (etripamil NS 70 mg with optional second dose of 70 mg etripamil or placebo) in a 1:1 ratio and could be enrolled in the open-label period to treat an additional PSVT episode with etripamil
• 1 arm consisting of participants that only received the Test Dose in Parts 2 and 3.

Conditions

Paroxysmal Supraventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1: Etripamil 70 mg Single Dose

Self-administration of a single dose etripamil 70 mg for a perceived episode of PSVT.

Group Type: EXPERIMENTAL

Etripamil

Intervention Type: DRUG

Etripamil 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.

Part 1: Placebo Single Dose

Self-administration of a single dose of placebo for a perceived episode of PSVT.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 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.

Part 1: Test dose only (etripamil 70 mg)

Single test dose of etripamil 70 mg in sinus rhythm

Group Type: OTHER

Etripamil Test Dose

Intervention Type: DRUG

During the Test Dose, etripamil 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.

Part 2 & Part 3: Etripamil 70 mg with Optional Second Dose

Self-administration of 70 mg etripamil for a perceived episode of PSVT followed 10 minutes later by an optional second dose of 70 mg etripamil, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.

Group Type: EXPERIMENTAL

Etripamil

Intervention Type: DRUG

Etripamil 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.

Part 2 & Part 3: Placebo with Optional Second Dose

Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 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.

Part 2 & Part 3: Test dose only (etripamil 70 mg + 70 mg)

Repeat Test Dose of etripamil 70 mg (2X 70mg) 10 minutes apart in sinus rhythm

Group Type: OTHER

Etripamil Test Dose

Intervention Type: DRUG

During the Test Dose, etripamil 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.

Interventions

Etripamil

Etripamil 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.

Intervention Type: DRUG

Placebo

Placebo 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.

Intervention Type: DRUG

Etripamil Test Dose

During the Test Dose, etripamil 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.

Intervention Type: DRUG

Other Intervention Names

MSP-2017; MSP-2017 Test Dose

Eligibility Criteria

Inclusion Criteria

Participants who met all of the following criteria were eligible to participate in the study:

1. Male or female participants at least 18 years of age;

2. Electrographically documented history of PSVT (e.g., electrocardiogram [ECG] obtained during an episode of PSVT, Holter monitoring, loop recorder, etc). If participant had a prior ablation for PSVT, participant had to have documented ECG evidence of PSVT post-ablation;

3. History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);

4. Females of childbearing potential who were sexually active with a male partner who were not surgically sterile (i.e., vasectomy) had to agree to use a highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug. Females of childbearing potential had to have a negative serum pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and had to use a highly effective form of contraception between the visits.

The following categories defined females who were NOT considered to be of childbearing potential:

• Premenopausal females with 1 of the following:

1. Documented hysterectomy,

2. Documented bilateral salpingectomy or tubal ligation; or

3. Documented bilateral oophorectomy, or

• Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause;

5. Male participants, except those who were surgically sterile, had to use an approved highly effective form of contraception during the 3 days after any study drug administration; and

6. Signed written informed consent.

Exclusion Criteria

Participants who met any of the following criteria were excluded from participation in the study:

1. Systolic blood pressure <90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the Test Dose. In participants treated with a chronic prophylactic drug for PSVT (e.g., beta-blockers, verapamil, and diltiazem), the drug could be stopped for at least the equivalent of 5 half-lives, participants could be rescreened once, and chronic use of the drug could not be restarted after randomization;

2. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;

3. History of atrial arrhythmia that did not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);

4. History of allergic reaction to verapamil;

5. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs were stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;

6. Current chronic therapy with oral amiodarone, or had taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;

7. Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval <100 msec, Wolff-Parkinson-White syndrome) on the ECG performed at the Screening Visit or before the Test Dose administration;

8. Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the Test Dose administration;

9. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or ventricular tachycardia);

10. Current congestive heart failure defined by the New York Heart Association Class II to IV;

11. History of Acute Coronary Syndrome or stroke within 6 months of screening;

12. Evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN at the Screening Visit, unless due to Gilbert syndrome;

13. Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of <15 mL/min/1.73m2, or requiring hemodialysis;

14. Females who were pregnant or lactating;

15. Evidence or history of any significant physical or psychiatric condition including drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of participants, or affect their participation in the study. Additionally, the Investigator had the ability to exclude a participant if for any reason the Investigator judged the participant was not a good candidate for the study or would not be able to follow study procedures;

16. Participation in any investigational drug or device study or the use of any investigational drug or device within 30 days of the Screening Visit; or

17. Previously enrolled in a clinical trial for etripamil and received study drug during a perceived episode of PSVT.

Before randomization in the study, all participants received a Test Dose of an etripamil NS dosing regimen (etripamil 70 NS mg in Part 1 and in Parts 2 and 3 an initial dose of etripamil NS 70 mg followed by a second dose of etripamil NS 70 mg not earlier than 10 minutes and not later than 15 minutes after the first dose) to evaluate tolerability and to train participants on the study procedures. Participants who passed the Test Dose were randomized in the NODE-301 (2:1) or RAPID and RAPID Extension (2:1) study. A failure of the Test Dose was considered if participants met any of the following criteria occurring after administration of the either the first or second dose of etripamil NS 70 mg:

1. Any symptoms consistent with clinically severe hypotension such as pre-syncope, medically significant lightheadedness, syncope, nausea, or vomiting;

2. For participants with a pre-Test Dose Systolic Blood Pressure above 100 mmHg:

1. Decrease in SBP ≥40 mmHg after Test Dose; or

2. Post-Test Dose SBP <80 mmHg;

3. For participants with a pre-Test Dose SBP between 90 mmHg and 100 mmHg (inclusive):

a) Post-Test Dose SBP <75 mmHg;

4. Third-degree AV block, Mobitz II second-degree AV block, or Wenckebach with bradycardia ≤40 bpm;

5. New, significant sinus bradycardia Heart Rate ≤40 bpm or sinus pauses (≤3 seconds), if considered by the Investigator to put the participant's safety at risk if either were to occur while not under medical supervision;

6. Any new ventricular arrhythmia considered significant by the Investigator; or

7. Atrial fibrillation, atrial flutter or atrial tachycardia (event lasting longer than 30 seconds);

8. Refusal of second dose of etripamil Test Dose regimen.

Participants who failed the Test Dose proceeded in the study as follows:

• If the Investigator identified a possible reversible cause of the initial Test Dose failure (e.g., concomitant medication such as beta-blocker), a re-challenge with a new Test Dose of etripamil dose regimen was possible after elimination of the reversible cause (e.g., withdrawal of concomitant therapy with the appropriate washout period). Participants could be randomized if they passed the second Test Dose and the cause of the Test Dose failure was eliminated for the duration of the study; or
• If the Investigator could not identify a reversible cause of the initial Test Dose failure, or if the potential cause could not be modified (e.g., necessary antihypertensive drug to control blood pressure), participants could not be randomized and completed a Final Study Visit. Participants who failed the Test Dose are part of the Test Dose Only Population.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

IQVIA Biotech

INDUSTRY

Sponsor Role: collaborator

Milestone Pharmaceuticals Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Bharucha, MD

Role: STUDY_DIRECTOR

Milestone Pharmaceuticals

Locations

Belvarosi Egeszseghaz

Zalaegerszeg, , Hungary

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Arkansas Cardiology

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Medvin Clinical Research

Cerritos, California, United States

North Coast Cardiolog

Encinitas, California, United States

Titan Medical Research - Oceanside

Encinitas, California, United States

Los Alamitos Cardiovascular

Los Alamitos, California, United States

Amicis Research Center - Northridge

Northridge, California, United States

RESPIRE Research

Palm Springs, California, United States

South Denver Cardiology Associates, P.C

Littleton, Colorado, United States

Cardiology Associates of Fairfield County

Norwalk, Connecticut, United States

FWD Clinical Research

Boca Raton, Florida, United States

Baptist Health Ambulatory Services d/b/a

Jacksonville, Florida, United States

United Health Research, LLC

Miami, Florida, United States

IACT Health

Columbus, Georgia, United States

Piedmont Heart Institute- Fayetteville

Fayetteville, Georgia, United States

Piedmont Heart Institute-Fayetteville

Fayetteville, Georgia, United States

Georgia Arrythmia Consultants&Research Institute

Macon, Georgia, United States

St. Luke's Idaho Cardiology Associates

Boise, Idaho, United States

Idaho Catalyst Clinical Research

Idaho Falls, Idaho, United States

AMITA Health Medical Group Heart & Vascular Elk Grpve Village

Elk Grove Village, Illinois, United States

Parkview Physicians Group - Cardiology

Fort Wayne, Indiana, United States

Mercy One Iowa Heart Center

West Des Moines, Iowa, United States

Clinical Trials of America, LLC - Monroe, LA

West Monroe, Louisiana, United States

MedStar Health Research Institute - Chesapeake Cardiovascular Associates

Baltimore, Maryland, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Revival Research Institute, LLC - Southgate, MI

Southgate, Michigan, United States

Mercy Research

St Louis, Missouri, United States

Cardiovascular Associates of the Delaware Valley - Elmer

Elmer, New Jersey, United States

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, United States

Columbia University

New York, New York, United States

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cary Research Group, LLC

Cary, North Carolina, United States

Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Hatton Institute for Research & Education, Trihealth, Inc. - Cardiology

Cincinnati, Ohio, United States

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, United States

Rama Research LLC

Marion, Ohio, United States

Heart House Research Foundation, LLC

Springfield, Ohio, United States

ProMedica Toledo Hospital

Toledo, Ohio, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Prisma Health Midlands

Columbia, South Carolina, United States

Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc

Rapid City, South Dakota, United States

North Texas Research Associates

Allen, Texas, United States

Cardiovascular Clinic of North Texas

Denton, Texas, United States

Revival Research Institute, LLC

Denton, Texas, United States

Apex Trials Group

Fort Worth, Texas, United States

Angiocardiac Care of Texas

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Scott & White Memorial Hospital: Baylor Scott & White Research Institute

Temple, Texas, United States

Bay Area Heart

Webster, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Clinique Du Sud- Luxembourg

Arlon, , Belgium

Imelda Hospital

Bonheiden, , Belgium

UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU)

Brussels, , Belgium

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Brussels, , Belgium

Antwerp University Hospital (UZA)

Edegem, , Belgium

Grand Hopital de Charleroi (GHdC) - Site Saint-Joseph

Gilly, , Belgium

Pharmacy Campus Virga Jesse (losplaats 7)

Hasselt, , Belgium

University Hospital (UZ) Leuven

Leuven, , Belgium

Regional Hospital Centre Citadelle

Liège, , Belgium

CHU Ambroise Pare

Mons, , Belgium

CHU UCL Namur - Site Godinne

Yvoir, , Belgium

Libin Cardiovascular Institute of Alberta - University of Calgary

Calgary, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Medical Arts Health Research Group - North Vancouver

North Vancouver, British Columbia, Canada

Vancouver Coastal Health Research

Vancouver, British Columbia, Canada

Victoria Cardiac Arrhythmia Trials, Inc.

Victoria, British Columbia, Canada

University of Manitoba, St Boniface General Hospital

Winnipeg, Manitoba, Canada

Dalhousie University - QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Cambridge Cardiac Care Centre

Cambridge, Ontario, Canada

Dawson Road Medical Centre

Guelph, Ontario, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic

Newmarket, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

The Montreal Heart Institute

Montreal, Quebec, Canada

CHUM Recherche Cardiologie

Montreal, Quebec, Canada

McGill University Health Center - Research Institute

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie De Quebec

Québec, Quebec, Canada

CardioVasc HR

Saint-Jean-sur-Richelieu, Quebec, Canada

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada

CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur

Terrebonne, Quebec, Canada

CHRU Besancon - Hopital Jean Minjoz

Besançon, Besancon, France

CHU Grenoble-Alpes - Hopital Michallon

La Tronche, Grenoble, France

CHRU de Brest - Hopital de la Cavale Blanche

Brest, , France

HCL Hopital Louis Pradel

Bron, , France

Hopital Saint-Louis de La Rochelle

La Rochelle, , France

CHU de Lille - Institut Cœur Poumon

Lille, , France

Centre Hospitalier de Pau

Pau, , France

Maerkische Gesundheitsholding GmbH - Klinikum Luedenscheid

Lüdenscheid, Ludenscheid, Germany

Peter Osypka Herzzentrum Munchen

München, Munchen, Germany

Vivantes Klinikum Neukoelln

Berlin, , Germany

FAZ Dresden-Neustadt GbR

Dresden, , Germany

Kardiologische Praxis

Dresden, , Germany

Kardiologische Gemeinschaftspraxis Papenburg

Papenburg, , Germany

Zentrum fuer Praevention und Rehabilitation

Siegen, , Germany

Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo

Békéscsaba, Bekescaba, Hungary

Nehezlegzes Ambulancia

Debrecen, Debrecon, Hungary

Del-pesti Centrumkorhaz

Budapest, , Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Debreceni Egyetem Klinikai

Debrecen, , Hungary

CRU Hungary Kft.

Encs, , Hungary

Meander Medisch Centrum - Locatie Amersfoort

Amersfoort, , Netherlands

Ziekenhuis Rijnstate - Locatie Arnhem

Arnhem, , Netherlands

Rode Kruis Ziekenhuis

Beverwijk, , Netherlands

Tergooiziekenhuizen Blaricum

Blaricum, , Netherlands

Amphia Ziekenhuis - Locatie Breda Molengracht

Breda, , Netherlands

IJsselland ziekenhuis

Capelle aan den IJssel, , Netherlands

Reinier de Graaf Gasthuis

Delft, , Netherlands

Deventer Ziekenhuis

Deventer, , Netherlands

Slingeland Ziekenhuis

Doetinchem, , Netherlands

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Ropcke-Zweers Ziekenhuis

Hardenberg, , Netherlands

Treant Zorggroep

Hoogeveen, , Netherlands

Alrijne Ziekenhuis

Leiderdorp, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

Franciscus Gasthuis & Vlietland - Locatie Vlietland

Schiedam, , Netherlands

Diakonessenhuis - Locatie Utrecht

Utrecht, , Netherlands

Jeroen Bosch Ziekenhuis

Utrecht, , Netherlands

American Heart of Poland S.A., IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii

Kędzierzyn-Koźle, Kedzierzyn Kozle, Poland

Gabinety Daszmed

Krakow, Krakov, Poland

Kliniczny Szpital Wojewódzki nr 2, Rzeszów

Rzeszów, Rzeszow, Poland

MICS Centrum Medyczne Torun

Bydgoszcz, , Poland

Centrum Medyczne Kermed

Bydgoszcz, , Poland

Specjalistyczna Praktyka Lekarska

Katowice, , Poland

Prywatny Specjalistyczny Gabinet Internistyczny

Libiąż, , Poland

MEDICOME Sp. z o.o.

Oświęcim, , Poland

SP ZOZ Szpital Specjalistyczny w Pulawach

Puławy, , Poland

NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych

Sopot, , Poland

Osrodek Badan Klinicznych CLINSANTE S.C.

Torun, , Poland

X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji

Tychy, , Poland

Kardiosystem

Warsaw, , Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi

Lodz, Łódź Voivodeship, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, Poland

Martínez Hervás Cardiólogos

Granada, Andalusia, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Cordoba, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, Spain

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital General Universitario de Valencia (HGUV)

Valencia, Valencia, Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

Granada, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Majadahonda, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Complejo Hospitalario de Navarra

Pamplona, , Spain

Hospital Universitari Sant Joan de Reus

Reus, , Spain

Hospital Universitario la Paz Rua Choupana

Santiago de Compostela, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital Universitario Clínico Lozano Blesa

Zaragoza, , Spain

Countries

United States; Belgium; Canada; France; Germany; Hungary; Netherlands; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 37331368 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36441560 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35728658 (View on PubMed)

Provided Documents

Document Type: Study Protocol: The RAPID study (NODE-301 Parts 2 and 3)

View Document

Document Type: Study Protocol: NODE-301 Part 1

View Document

Document Type: Statistical Analysis Plan: The RAPID study (NODE-301 Parts 2 and 3)

View Document

Document Type: Statistical Analysis Plan: NODE-301 Part 1

View Document

Other Identifiers

2018-000308-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MSP-2017-1138

Identifier Type: -

Identifier Source: org_study_id