Persistent Nonvalvular Atrial FibrillationPhase 3NCT00171769
Atrial Fibrillation Feasibility Certoparin Trial - AFFECT
A Phase 3 study testing Certoparin in people with Persistent Nonvalvular Atrial Fibrillation, run by Novartis at 2 sites in 2 countries.
Trial summary
This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Nonvalvular Atrial Fibrillation
- What is being tested?
- Certoparin
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2005to Aug 2006
- Phase
- Phase 3
- 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
- persistent AF (electrical cardioversion is planned)
- written informed consent
Who cannot join
- acute clinical signs of venous thromboembolism
- current oral anticoagulation
- indication for medical cardioversion
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: An Open Label, Multi-center Trial to Evaluate the Feasibility and Safety of Short-term Treatment With Subcutaneously Injected Certoparin (8000 U Anti-Xa Twice Daily) in Patients With Persistent Nonvalvular Atrial Fibrillation
This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation
- Being tested
- Certoparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CertoparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Nonvalvular 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- novartis pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171769
- Sponsor's protocol ID
- CMEX839BDE01
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Tebbe U, Oeckinghaus R, Appel KF, Heuer H, Haake H, Eggers E, Seidel K, Adams J, Harenberg J. AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation. Clin Res Cardiol. 2008 Jun;97(6):389-96. doi: 10.1007/s00392-008-0644-y. Epub 2008 Mar 5.
PubMed 18322636
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-center Trial to Evaluate the Feasibility and Safety of Short-term Treatment With Subcutaneously Injected Certoparin (8000 U Anti-Xa Twice Daily) in Patients With Persistent Nonvalvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00171769
- Acronym / sponsor ID
- CMEX839BDE01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Aug 2006 (actual)
- First posted
- 15 Sep 2005 (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.
This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- persistent AF (electrical cardioversion is planned)
- written informed consent
Key exclusion criteria (3 listed)
- acute clinical signs of venous thromboembolism
- current oral anticoagulation
- indication for medical cardioversion
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 |
|---|---|---|
| Certoparin | Drug | – |
Primary outcome
Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Results publication: PubMed 18322636Tebbe U, Oeckinghaus R, Appel KF, Heuer H, Haake H, Eggers E, Seidel K, Adams J, Harenberg J. AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation. Clin Res Cardiol. 2008 Jun;97(6):389-96. doi: 10.1007/s00392-008-0644-y. Epub 2008 Mar 5.
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.
novartis pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certoparin in people with Persistent Nonvalvular Atrial Fibrillation, run by Novartis at 2 sites in 2 countries.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00171769, which also lists 1 linked publication.
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 23 Feb 2017; AzTrials last refreshed its copy on 3 Nov 2026.