Atrial FibrillationPhase 2NCT00157248
Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048
A Phase 2 study testing dabigatran etexilate in people with Atrial Fibrillation and Stroke, run by Boehringer Ingelheim at 50 sites in 4 countries.
Trial summary
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- dabigatran etexilate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 50 sitesin 4 countries
- Study dates
- Dec 2003to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- previous treatment with BIBR 1048 in PETRO (trial 1160.20- NCT01227629) and no premature discontinuation of therapy
- paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ECG) at least twice prior to enrollment in PETRO
- concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (DM), congestive heart failure (CHF) or Left ventricular dysfunction (LVD), previous ischemic stroke or transient ischemic attack) TIA, or age greater than 75 years. -age >= 18 years
- written, informed consent
Who cannot join
- Valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study.
- contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (GI) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (INR), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than GI hemorrhage).
- severe renal impairment (estimated glomerular filtration rate [GFR] <= 30 mL/min). uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg and/or diastolic blood pressure [DBP] > 100 mmHg).
- Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (note: a negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study).
- Patients who have received an investigational drug other than BIBR 1048 within the last 30 days.
- Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration. Another indication for anticoagulant treatment (eg, deep vein thrombosis or pulmonary embolus). Clinically significant anemia (note: patients with mild-moderate anemia should only be enrolled after the possibility of a GI bleeding source has been evaluated, the etiology of the anemia identified, and appropriate action taken). Patients suffering from thrombocytopenia (platelets < 100,000/uL). Any other condition which, in the discretion of the investigator, would not allow safe participation in the study.
- Continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (ASA).
- Recent malignancy or radiation therapy (<= 6 months).
Trial locations and contacts
50 sites in 4 countries.
50 sites in 4 countries
Denmark13 sites
1160.42.45010 Boehringer Ingelheim Investigational Site
Aalborg
1160.42.45005 Boehringer Ingelheim Investigational Site
Aarhus C
1160.42.45007 Boehringer Ingelheim Investigational Site
Brædstrup
1160.42.45003 Boehringer Ingelheim Investigational Site
Elsinore
1160.42.45011 Boehringer Ingelheim Investigational Site
Esbjerg
1160.42.45012 Boehringer Ingelheim Investigational Site
Frederikssund
1160.42.45004 Boehringer Ingelheim Investigational Site
Herlev
1160.42.45009 Boehringer Ingelheim Investigational Site
Holbæk
1160.42.45002 Boehringer Ingelheim Investigational Site
Hvidovre
1160.42.45014 Boehringer Ingelheim Investigational Site
Køge
1160.42.45001 Boehringer Ingelheim Investigational Site
Odense
1160.42.45013 Roskilde Sygehus
Roskilde
1160.42.45006 Boehringer Ingelheim Investigational Site
Svendborg
Netherlands13 sites
1160.42.31003 Ziekenhuis Amstelveen
Amstelveen
1160.42.31001 Academisch Medisch Centrum
Amsterdam
1160.42.31013 Onze Lieve Vrouwe Gasthuis
Amsterdam
1160.42.31008 Gelre Ziekenhuis, locatie Juliana
Apeldoorn
1160.42.31006 Wilhelmina Ziekenhuis
Assen
1160.42.31007 Gemini Ziekenhuis
Den Helder
1160.42.31002 Ziekenhuis Gelderse Vallei
Ede
1160.42.31014 Ziekenhuisgroep Twente
Hengelo
1160.42.31012 Vasculair onderzoekscentrum (VOC)
Hoorn
1160.42.31009 Havenziekenhuis
Rotterdam
1160.42.31004 Maasland Ziekenhuis
Sittard
1160.42.31005 Tweesteden Ziekenhuis
Tilburg
1160.42.31011 Maxima Medisch Centrum
Veldhoven
United States12 sites
1160.42.10015 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1160.42.10014 Boehringer Ingelheim Investigational Site
Hawthorne, New York
1160.42.10003 Boehringer Ingelheim Investigational Site
La Mesa, California
1160.42.10013 Boehringer Ingelheim Investigational Site
New Hyde Park, New York
1160.42.10009 Boehringer Ingelheim Investigational Site
North Durham, North Carolina
1160.42.10006 Boehringer Ingelheim Investigational Site
Pensacola, Florida
1160.42.10001 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1160.42.10012 Boehringer Ingelheim Investigational Site
Pittsfield, Massachusetts
1160.42.10004 Boehringer Ingelheim Investigational Site
Port Charlotte, Florida
1160.42.10002 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
1160.42.10007 Boehringer Ingelheim Investigational Site
Troy, Michigan
1160.42.10008 Boehringer Ingelheim Investigational Site
Westminster, Maryland
Sweden12 sites
1160.42.46013 Boehringer Ingelheim Investigational Site
Eskilstuna
1160.42.46007 Boehringer Ingelheim Investigational Site
Falun
1160.42.46005 Boehringer Ingelheim Investigational Site
Jönköping
1160.42.46010 Boehringer Ingelheim Investigational Site
Kalmar
1160.42.46009 Boehringer Ingelheim Investigational Site
Malmö
1160.42.46008 Boehringer Ingelheim Investigational Site
Norrköping
1160.42.46004 Boehringer Ingelheim Investigational Site
Örebro
1160.42.46002 Boehringer Ingelheim Investigational Site
Stockholm
1160.42.46011 Boehringer Ingelheim Investigational Site
Stockholm
1160.42.46006 Boehringer Ingelheim Investigational Site
Umeaa
1160.42.46001 Boehringer Ingelheim Investigational Site
Uppsala
1160.42.46003 Boehringer Ingelheim Investigational Site
Västerås
About this study
Official title: Long-term, Open-label Follow-up Treatment of Patients With Atrial Fibrillation Who Have Been Previously Treated With BIBR 1048 in the PETRO Trial (Trial 1160.20 - NCT01227629). (PETRO Extension Trial: PETRO-Ex)
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- dabigatran etexilate
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabigatran etexilateDrug
dosage used at study start
dabigatran etexilateDrug
dosage used at study start
dabigatran etexilateDrug
dosage used at study start
dabigatran etexilateDrug
dosage used at study start
| Study group | Role | What they receive |
|---|---|---|
| dabigatran etexilate, 150 mg once daily | Experimental | dosage used at study start Receives: Drug: dabigatran etexilate |
| dabigatran etexilate, 150 mg twice daily | Experimental | dosage used at study start Receives: Drug: dabigatran etexilate |
| dabigatran etexilate, 300 mg once daily | Experimental | dosage used at study start Receives: Drug: dabigatran etexilate |
| dabigatran etexilate, 300 mg twice daily | Experimental | dosage used at study start Receives: Drug: dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.
Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate for Major Bleeding
Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate for Major + Minor/Relevant Bleeding
Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate for Any Bleeding
Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate for Minor Bleeding
Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds.
Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Secondary outcomes (11)
Yearly Event Rate for Stroke
Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate of Ischaemic Stroke
Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate of Haemorrhagic Stroke
Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate for Transient Ischaemic Attacks
Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate for Systemic Thromboembolism
Time to first occurrence of any non-central nervous system systemic thromboembolism.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate of Myocardial Infarction
Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate of Other Major Adverse Cardiac Events
Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate of Death
Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality
Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Measured: 5 years
Severe Adverse Event
Frequency of patients with severe adverse events.
Measured: 5 years
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range.
Normal ranges are defined as:
- Alanine aminotransferase (ALT): 5-45 [U/L]
- Aspartate aminotransferase (AST): 10-40 [U/L]
- Bilirubin, total: 0.2-1.0 [mg/dL]
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157248
- Sponsor's protocol ID
- 1160.42
- Status last verified
- Feb 2014
- First submitted
- 8 Sep 2005
- Last updated
- 19 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term, Open-label Follow-up Treatment of Patients With Atrial Fibrillation Who Have Been Previously Treated With BIBR 1048 in the PETRO Trial (Trial 1160.20 - NCT01227629). (PETRO Extension Trial: PETRO-Ex)
- ClinicalTrials.gov ID
- NCT00157248
- Acronym / sponsor ID
- 1160.42
- Conditions
- Atrial Fibrillation, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Jan 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 3 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dabigatran etexilate, 150 mg once daily | Experimental | Drug: dabigatran etexilatedosage used at study start |
| dabigatran etexilate, 150 mg twice daily | Experimental | Drug: dabigatran etexilatedosage used at study start |
| dabigatran etexilate, 300 mg once daily | Experimental | Drug: dabigatran etexilatedosage used at study start |
| dabigatran etexilate, 300 mg twice daily | Experimental | Drug: dabigatran etexilatedosage used at study start |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- previous treatment with BIBR 1048 in PETRO (trial 1160.20- NCT01227629) and no premature discontinuation of therapy
- paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ECG) at least twice prior to enrollment in PETRO
- concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (DM), congestive heart failure (CHF) or Left ventricular dysfunction (LVD), previous ischemic stroke or transient ischemic attack) TIA, or age greater than 75 years. -age >= 18 years
- written, informed consent
Key exclusion criteria (8 listed)
- Valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study.
- contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (GI) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (INR), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than GI hemorrhage).
- severe renal impairment (estimated glomerular filtration rate [GFR] <= 30 mL/min). uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg and/or diastolic blood pressure [DBP] > 100 mmHg).
- Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (note: a negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study).
- Patients who have received an investigational drug other than BIBR 1048 within the last 30 days.
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 |
|---|---|---|
| dabigatran etexilatedosage used at study start | Drug | dabigatran etexilate, 150 mg once daily |
| dabigatran etexilatedosage used at study start | Drug | dabigatran etexilate, 150 mg twice daily |
| dabigatran etexilatedosage used at study start | Drug | dabigatran etexilate, 300 mg once daily |
| dabigatran etexilatedosage used at study start | Drug | dabigatran etexilate, 300 mg twice daily |
Primary outcome
Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.
Time frame: 5 years
Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Major Bleeding
Time frame: 5 years
Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Major + Minor/Relevant Bleeding
Time frame: 5 years
Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Any Bleeding
Time frame: 5 years
Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Minor Bleeding
Time frame: 5 years
Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds. Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
11 secondary outcomes
Yearly Event Rate for Stroke
Time frame: 5 years
Yearly Event Rate of Ischaemic Stroke
Time frame: 5 years
Yearly Event Rate of Haemorrhagic Stroke
Time frame: 5 years
Yearly Event Rate for Transient Ischaemic Attacks
Time frame: 5 years
Yearly Event Rate for Systemic Thromboembolism
Time frame: 5 years
Yearly Event Rate of Myocardial Infarction
Time frame: 5 years
Yearly Event Rate of Other Major Adverse Cardiac Events
Time frame: 5 years
Yearly Event Rate of Death
Time frame: 5 years
Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality
Time frame: 5 years
Severe Adverse Event
Time frame: 5 years
Laboratory Analyses
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
50 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dabigatran etexilate in people with Atrial Fibrillation and Stroke, run by Boehringer Ingelheim at 50 sites in 4 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 4 inclusion and 8 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Denmark, Netherlands, United States, Sweden. 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 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?
Yes. Results are posted in the registry (first posted 3 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality. (time frame: 5 years). The study lists 5 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 19 May 2014.