Stable or Unstable Angina PectorisPhase 3NCT00396929
Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies
A Phase 3 study testing local intracoronary dosis of Paclitaxel in people with Stable or Unstable Angina Pectoris and Myocardial Ischemia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The aim of the study is to examine the efficacy of Paclitaxel injection after a stent implantation in patients with stenosis in native coronary arteries to prevent restenosis in comparision with two admitted therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stable or Unstable Angina Pectoris, Myocardial Ischemia
- What is being tested?
- local intracoronary dosis of Paclitaxel
- How many people
- 204 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Jul 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18 to 80, males or females
- stable or instable angina pectoris and or/ documented myocardial ischemia
- willingness and ability to adhere to the study conditions
- written informed consent after patient information
- De-novo stenosis of coronary artery with a degree of stenosis between 50% and 99%, that is accessible to PTCA
- Target vessels diameter of at least 2,5 mm and length of lesion below 18 mm
Who cannot join
- Acute myocardial infarction or still elevated CK/CK-MB after acute myocardial infarction
- known severe arrhythmias that necessitate a long term antiarrhythmic therapy
- pericarditis
- intracardiac thrombus
- Bacterial endocarditis
- Cardiopulmonary reanimation with cardiac massage within the last 6 months
Show all 29Show fewer
- Thromboembolic accident within the last 6 months
- Severe peripheral arterial occlusive disease, that excludes the use of a 6 French catheter or that requires a special antithrombotic or anticoagulatory regime
- Manifest hyperthyreosis
- Neutrohile granulocytes less than 3000/mm3 and platelets below 100.000 or above 700.000/mm3
- Renal insufficiency with serum creatinine above 1,5 mg/L
- severe systemic hypertension despite antihypertensive medication
- other diseases which might lead to protocol violations or reduce life expectancy
- significant upper intestinal bleeding within the last 6 months
- life expectancy < 1 year
- poor general condition
- Premenopausal women, women who are postmenopausal less than 2 years
- known allergy or hypersensitivity to Paclitaxel, to one of the TAXOL-components, to one of the stent components, to acetylsalicylic acid, heparin, clopidogrel or contrast agent
- Concurrent participation or participation within the last 30 days prior to screening in another drug trial or a trial with a medical device
- absence of written declaration of consent
- inability, to understand sense and purpose of the study or not willing to keep the conditions of the study
- Bifurcation stenosis, ostium stenosis, main stem stenosis ot the target vessel
- visible thrombus in target vessel
- Severely curved or sclerosed target vessel
- complete closure of target vessel
- Severe impairment of left ventricular function with left ventricular ejection fraction of less than 30%
- Patients with expected indication for operative myocardial revascularisation within the next six months
- patients with contraindication for aortocoronary bypass operation,
- patients, who are principally not available for a second coronary angiography 6 months after stent implantation or who have a contraindication for a second coronary angiography
Trial locations and contacts
1 site in 1 country.
Germany1 site
Abteilung Kardiologie und Kreislauferkrankungen, Medizinische Universitätsklinik und Poliklinik III, Universitätsklinikum Tübingen
Tübingen, 72076
About this study
Official title: Local-Tax Trial: Local Intracoronary Administration of Paclitaxel After Stent Implantation for Prevention of Restenosis in Comparison With Stent Implantation Alone and With Implantation of a Paclitaxel-Eluting Stent
The aim of the study is to examine the efficacy of Paclitaxel injection after a stent implantation in patients with stenosis in native coronary arteries to prevent restenosis in comparision with two admitted therapies.
Read the detailed description
The aim of the study is to examine whether in patients with stable or instable Angina pectoris and/or documented myocardial ischemia in the presence of de-novo stenosis in native coronary arteries with a degree of stenosis between 50 % and 99 % an additional local administration of paclitaxel after implantation of a conventional stent is superior to the implantation of a conventional stent alone with respect to late lumen loss (LLL). In case of superiority it will be examined whether an additional local administration of paclitaxel after implantation of a conventional stent is not inferior to the implantation of a paclitaxel-eluting stent with respect to late lumen-luss. Is this the case, superiority will be tested.
- Being tested
- local intracoronary dosis of Paclitaxel
- Keywords
- Paclitaxel, Restenosis, Stent, Intracoronary Dosis, Paclitaxel-eluting Stent
- Medical subject headings
- Angina, Unstable, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local intracoronary dosis of PaclitaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is the angiographical determination of the late lumen loss in the stent and/or persistent area, 6 month after stent implantation.
Measured: week 26 +/- 14 days
Secondary outcomes (4)
The angiographical determination of the binary restenosis rate, defined as diameter stenosis of at least 50 % in the stent and / or persistent area, 6 months after stent implantation.
Measured: week 26 +/- 14 days
The angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and /or persistent area, 6 months after stent implantation.
Measured: week 26, +/- 14 days
Tthe angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation.
Measured: week 26, +/- 14 days
The 6 months after stent implantation determined combined endpoint of abrupt and subabrupt closure of the target vessel, target lesion revascularisation and major adverse cardiac events including myocardial infarction and death.
Measured: week 26, +/-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startAug 2005
- Study completionJul 2007 (estimated)
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 Stable or Unstable Angina PectorisStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Acrostak
- Investigators
- Christian Herdeg, PD, Principal investigator, Universitätsklinikum Tübingen, Medizinische Universitäts und Poliklinik III, Abteilung Kardiologie und Kreislauferkrankungen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396929
- Sponsor's protocol ID
- TAX-001
- Other IDs
- 2005-001481-14, 2005
- Status last verified
- May 2007
- First submitted
- 7 Nov 2006
- Last updated
- 16 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.
PubMed 20031731
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local-Tax Trial: Local Intracoronary Administration of Paclitaxel After Stent Implantation for Prevention of Restenosis in Comparison With Stent Implantation Alone and With Implantation of a Paclitaxel-Eluting Stent
- ClinicalTrials.gov ID
- NCT00396929
- Acronym / sponsor ID
- TAX-001
- Keywords
- Paclitaxel, Restenosis, Stent, Intracoronary Dosis, Paclitaxel-eluting Stent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Acrostak
- Study start
- Aug 2005
- Study completion
- Jul 2007 (estimated)
- First posted
- 8 Nov 2006 (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.
The aim of the study is to examine the efficacy of Paclitaxel injection after a stent implantation in patients with stenosis in native coronary arteries to prevent restenosis in comparision with two admitted therapies.
Detailed description
The aim of the study is to examine whether in patients with stable or instable Angina pectoris and/or documented myocardial ischemia in the presence of de-novo stenosis in native coronary arteries with a degree of stenosis between 50 % and 99 % an additional local administration of paclitaxel after implantation of a conventional stent is superior to the implantation of a conventional stent alone with respect to late lumen loss (LLL). In case of superiority it will be examined whether an additional local administration of paclitaxel after implantation of a conventional stent is not inferior to the implantation of a paclitaxel-eluting stent with respect to late lumen-luss. Is this the case, superiority will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age: 18 to 80, males or females
- stable or instable angina pectoris and or/ documented myocardial ischemia
- willingness and ability to adhere to the study conditions
- written informed consent after patient information
- De-novo stenosis of coronary artery with a degree of stenosis between 50% and 99%, that is accessible to PTCA
Key exclusion criteria (29 listed)
- Acute myocardial infarction or still elevated CK/CK-MB after acute myocardial infarction
- known severe arrhythmias that necessitate a long term antiarrhythmic therapy
- pericarditis
- intracardiac thrombus
- Bacterial endocarditis
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 |
|---|---|---|
| local intracoronary dosis of Paclitaxel | Drug | – |
Primary outcome
The primary objective is the angiographical determination of the late lumen loss in the stent and/or persistent area, 6 month after stent implantation.
Time frame: week 26 +/- 14 days
4 secondary outcomes
The angiographical determination of the binary restenosis rate, defined as diameter stenosis of at least 50 % in the stent and / or persistent area, 6 months after stent implantation.
Time frame: week 26 +/- 14 days
The angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and /or persistent area, 6 months after stent implantation.
Time frame: week 26, +/- 14 days
Tthe angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation.
Time frame: week 26, +/- 14 days
The 6 months after stent implantation determined combined endpoint of abrupt and subabrupt closure of the target vessel, target lesion revascularisation and major adverse cardiac events including myocardial infarction and death.
Time frame: week 26, +/-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2007.
- Derived from this study: PubMed 20031731Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.
Related trials for Stable or Unstable Angina Pectoris
RecruitingObservational study
SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
Coronary Disease, Coronary Artery Disease
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.
Christian Herdeg, PD principal investigator
Universitätsklinikum Tübingen, Medizinische Universitäts und Poliklinik III, Abteilung Kardiologie und Kreislauferkrankungen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing local intracoronary dosis of Paclitaxel in people with Stable or Unstable Angina Pectoris and Myocardial Ischemia, run by University Hospital Tuebingen at 1 site in Germany.
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 6 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 16 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
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?
The primary objective is the angiographical determination of the late lumen loss in the stent and/or persistent area, 6 month after stent implantation. (time frame: week 26 +/- 14 days). 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 NCT00396929, 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 16 May 2007.