Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients with Atrial Fibrillatio
- Conditions
- Abnormal heart rhythmarrhythmia10007521
- Registration Number
- NL-OMON51562
- Lead Sponsor
- Milestone Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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 on an ECG
4. Patients should receive appropriate antithrombotic therapy as per Canadian
Cardiovascular Society (CCS) 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 CCS guidelines may start after the administration of
study drug.
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
chanel 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 drugs 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to demonstrate the superiority of<br /><br>etripamil NS over placebo in reducing ventricular rate in patients with AF. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to evaluate the safety and efficacy of etripamil NS<br /><br>in patients with AF. </p><br>