Atrial FibrillationPhase 2ARCTIC-AFNCT01067833
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
A Phase 2 study testing K201 Tablet in people with Atrial Fibrillation, run by Sequel Pharmaceuticals, Inc.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- K201 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
About this study
Official title: A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary EffiCacy Study of K201 Oral for the Prevention of ATrial FIbrillation (AF) Recurrence in Subjects Post-Conversion From AF
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).
- Conditions
- Atrial Fibrillation
- Being tested
- K201 Tablet, Placebo Tablet
- Keywords
- atrial fibrillation, AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K201 TabletDrug
oral tablet, x28 days
Placebo TabletDrug
oral tablet, x28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Tablet |
| Dose 1 | Experimental | K201 Receives: Drug: K201 Tablet |
| Dose 2 | Experimental | K201 Receives: Drug: K201 Tablet |
| Dose 3 | Experimental | K201 Receives: Drug: K201 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first documented recurrence of symptomatic AF
Measured: 28 days
time to first documented recurrence of symptomatic or asymptomatic AF
Measured: 28 days
proportion of subjects in sinus rhythm
Measured: Day 28
number of AF beats
Measured: 10 days
time in AF
Measured: 10 days
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequel Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Chamberlin, MD, Study director, Sequel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067833
- Sponsor's protocol ID
- CJO-201
- Acronym
- ARCTIC-AF
- Status last verified
- May 2011
- First submitted
- 10 Feb 2010
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary EffiCacy Study of K201 Oral for the Prevention of ATrial FIbrillation (AF) Recurrence in Subjects Post-Conversion From AF
- ClinicalTrials.gov ID
- NCT01067833
- Acronym / sponsor ID
- ARCTIC-AF / CJO-201
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, AF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sequel Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo TabletPlacebo |
| Dose 1 | Experimental | Drug: K201 TabletK201 |
| Dose 2 | Experimental | Drug: K201 TabletK201 |
| Dose 3 | Experimental | Drug: K201 TabletK201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K201 Tabletoral tablet, x28 days | Drug | Dose 1, Dose 2, Dose 3 |
| Placebo Tabletoral tablet, x28 days | Drug | Placebo |
Primary outcome
time to first documented recurrence of symptomatic AF
Time frame: 28 days
time to first documented recurrence of symptomatic or asymptomatic AF
Time frame: 28 days
proportion of subjects in sinus rhythm
Time frame: Day 28
number of AF beats
Time frame: 10 days
time in AF
Time frame: 10 days
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
Time frame: 42 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Chamberlin, MD study director
Sequel Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K201 Tablet in people with Atrial Fibrillation, run by Sequel Pharmaceuticals, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first documented recurrence of symptomatic AF (time frame: 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2011.