The ReVeRA-201 Trial : Etripamil in Atrial Fibrillatio
- Conditions
- Treatment of Atrial FibrillationMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2022-001854-49-NL
- Lead Sponsor
- Milestone Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Aged 18 years and over
2. Has provided written informed consent
3. Patients with episodes of paroxysmal, persistent or permanent AF,
presenting with AF and a ventricular rate =110 bpm measured over
1 minute
4. Patients should receive appropriate antithrombotic therapy as per
the applicable guidelines for AF management (e.g. Canadian
Cardiovascular Society (CCS) / European Society of Cardiology
(ESC) guidelines).
a. Etripamil (a calcium channel blocker) is intended for acute
rate control only. If rhythm control is desired (outside of
the present protocol), anticoagulation as per guidelines may
start after the administration of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Has evidence of atrial flutter (ECG) at presentation
2. Has a history of stroke, transient ischemic attack or peripheral
embolism within the last 3 months
3. Has received by IV route any of the following within one hour
before study drug administration: flecainide, procainamide,
digoxin, beta-blocker, or calcium channel blocker
4. Has signs and symptoms of severe congestive heart failure at
presentation (e.g. tachypnea, oxygen desaturation <90% unless due
to known pulmonary disease, pulmonary rales, sign of peripheral
hypoperfusion)
5. Hemodynamic instability, with systolic blood pressure <90 mmHg
or diastolic blood pressure <60 mmHg
6. Known uncorrected severe aortic or mitral stenosis
7. Hypertrophic cardiomyopathy with outflow tract obstruction
8. Has a history of second- or third-degree atrioventricular block
9. Regular rhythm suggesting a complete AV block
10. Has a history or evidence of torsades de pointes, sick sinus
syndrome, or Brugada syndrome
11. Evidence of Acute Coronary Syndrome within the last 12 months
except if patient was successfully revascularized
12. Positive pregnancy test result at screening, and females of
childbearing potential who do not agree to use adequate method of
contraception for the duration of the study.
13. Has evidence of any clinically significant acute or chronic condition
of the nasal cavity (e.g., rhinitis or deviated septum) which could
interfere with administration of the study drug in either or both
nasal cavities
14. Has a history of sensitivity to verapamil
15. Has previously participated in a clinical study for etripamil
16. Has a history of sensitivity to any components of the investigational
product
17. Signs of alcohol or drug intoxication at the time of presentation
which, in the opinion of the Investigator, would impact the validity
of study results
18. Is currently participating in another drug or device study, or has
received an investigational drug or device within 30 days of
Screening
19. Has evidence of clinically significant cardiovascular, endocrine,
gastrointestinal, hematologic, hepatic, immunologic, neurologic,
oncologic, pulmonary, psychiatric, or renal disease or any other
condition which, in the opinion of the Investigator, would
jeopardize the safety of the patient or impact the validity of study
results
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method