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Phase 2 Study of Oral K201 for Prevention of AF Recurrence (ARCTIC-AF)

S

Sequel Pharmaceuticals

Status and phase

Terminated
Phase 2

Conditions

Atrial Fibrillation

Treatments

Drug: Placebo Tablet
Drug: K201 Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01067833
CJO-201

Details and patient eligibility

About

To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration >3 days and <6 months).

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Symptomatic AF (sustained >3 days and <6 months) and clinically indicated for cardioversion;
  • Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;
  • Hemodynamically stable (90 mmHg < systolic blood pressure < 190 mmHg)at screening and on Day 1;

Exclusion criteria

  • Known prolonged QT syndrome or QTc interval of >0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);
  • QRS >0.130 sec;
  • Previous episodes of second- or third-degree atrioventricular block;
  • Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;
  • Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);
  • Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
  • NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;
  • Known concurrent temporary secondary causes of AF;
  • Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
  • Received treatment with other drugs known to prolong the QT interval within 5 half-lives.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo Tablet
Dose 1
Experimental group
Description:
K201
Treatment:
Drug: K201 Tablet
Dose 2
Experimental group
Description:
K201
Treatment:
Drug: K201 Tablet
Dose 3
Experimental group
Description:
K201
Treatment:
Drug: K201 Tablet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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