Coronary Artery DiseasePhase 1/2NCT01140204
Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
A Phase 1/2 study testing Implantation of a bare metal stent in people with Coronary Artery Disease, run by University Hospital, Saarland at 2 sites in Germany.
Trial summary
This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose level, with four ascending dose levels to test the tolerability and safety of iopromide-paclitaxel in patients with de novo lesions in coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Implantation of a bare metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2003to Jun 2004
- Phase
- Phase 1/2
- 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
- male and postmenopausal female patients
- aged 18 years and older
- clinical evidence of stable or unstable angina, a positive functional test and a stentable de novo lesion in a native coronary artery
- diameter stenosis > 70% (visual estimate), lesion length < 25 mm, and a vessel diameter ≥ 2.5 mm.
Who cannot join
- acute myocardial infarction
- left ventricular ejection fraction of < 30%
- aorto-ostial lesion
- unprotected left main lesion or a bypass graft
- clear angiographic calcification in the target lesion
- visible thrombus proximal to the lesion
Show all 12Show fewer
- chronic total occlusion
- platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- WBC <3,000 cells/mm3
- known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, stainless steel
- sensitivity to contrast media not amenable to adequate premedication
- medical illness (i.e. cancer, liver disease or congestive heart failure) associated with a life expectancy of less than two years
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charite University Hospital
Berlin, 10117
University Hospital of Saarland
Homburg/Saar, Saarland, 66421
About this study
Official title: Restenosis Inhibition by Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose level, with four ascending dose levels to test the tolerability and safety of iopromide-paclitaxel in patients with de novo lesions in coronary arteries. Thirty-two patients were included into the trial, which were divided into four treatment groups. A total of four concentration levels of paclitaxel-iopromide concentrations were investigated. In each treatment group, six patients received iopromide-paclitaxel and two patients placebo (iopromide without paclitaxel). In each patient, the doses were adjusted individually as needed.
Read the detailed description
Background: Non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and initial clinical trials. Paclitaxel dissolved in the angiographic contrast agent iopromide was well tolerated and inhibited neointimal proliferation in a dose-dependent manner after injection into porcine coronary arteries.
Methods: As a first step in entering clinical development, a phase I trial was performed using 4 ascending paclitaxel dose/concentration levels: samples of up to 100 ml of the contrast agent containing 10, 50, 100 or 200 μM paclitaxel were randomly administered to 6 adult patients each assigned to bare metal stent implantation for single de novo coronary artery lesions, while 8 patients treated with plain contrast medium served as controls. Safety variables and tolerability as well as angiographic parameters were assessed.
- Conditions
- Coronary Artery Disease
- Being tested
- Implantation of a bare metal stent
- Keywords
- stent, contrast media, paclitaxel, stent implantation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a bare metal stentDevice
Bare Metal Stent
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | Contrast medium without Paclitaxel Receives: Device: Implantation of a bare metal stent |
| Iopromide Paclitaxel 0.85 mg | Active comparator | Iopromide Paclitaxel 0.85 mg Receives: Device: Implantation of a bare metal stent |
| Iopromide Paclitaxel 4.27 mg | Active comparator | Iopromide Paclitaxel 4.27 mg Receives: Device: Implantation of a bare metal stent |
| Iopromide Paclitaxel 8.54 mg | Active comparator | Iopromide Paclitaxel 8.54 mg Receives: Device: Implantation of a bare metal stent |
| Iopromide Paclitaxel 17.08 mg | Active comparator | Iopromide Paclitaxel 17.08 mg Receives: Device: Implantation of a bare metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intracoronary application
- Continuous monitoring electrocardiogram (ECG)
- Vital signs
- Invasive measure of blood pressure
- Lab variables: red blood count, white blood count, diff, creatinine kinase, creatinine kinase - muscle bound, creatinine
- Cmax of paclitaxel in serum
- 12-lead ECG
- Adverse events
Measured: ca. 30 minutes (during intervention)
Secondary outcomes (3)
Late lumen loss
Difference between angiographic in-stent minimum lumen diameter at 6 months follow-up and post-intervention
Measured: 6 months
Restenosis rate
Defined as a diameter stenosis of ≥50% (assessed by quantitative coronary angiography) at any control angiography
Measured: 6 months
Combined clinical endpoints (Major adverse cardiac events, MACE)
- Abrupt and sub-abrupt closure
- Target lesion revascularization
- Myocardial infarction
- Death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startMar 2003
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Scheller, MD, Principal investigator, University Hospital, SaarlandWolfgang Rutsch, MD, Principal investigator, Charite Hospital, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140204
- Sponsor's protocol ID
- 1-325-02
- Status last verified
- Apr 2023
- First submitted
- 7 Jun 2010
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restenosis Inhibition by Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
- ClinicalTrials.gov ID
- NCT01140204
- Acronym / sponsor ID
- 1-325-02
- Conditions
- Coronary Artery Disease
- Keywords
- stent, contrast media, paclitaxel, stent implantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 9 Jun 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.
This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose level, with four ascending dose levels to test the tolerability and safety of iopromide-paclitaxel in patients with de novo lesions in coronary arteries. Thirty-two patients were included into the trial, which were divided into four treatment groups. A total of four concentration levels of paclitaxel-iopromide concentrations were investigated. In each treatment group, six patients received iopromide-paclitaxel and two patients placebo (iopromide without paclitaxel). In each patient, the doses were adjusted individually as needed.
Detailed description
Background: Non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and initial clinical trials. Paclitaxel dissolved in the angiographic contrast agent iopromide was well tolerated and inhibited neointimal proliferation in a dose-dependent manner after injection into porcine coronary arteries.
Methods: As a first step in entering clinical development, a phase I trial was performed using 4 ascending paclitaxel dose/concentration levels: samples of up to 100 ml of the contrast agent containing 10, 50, 100 or 200 μM paclitaxel were randomly administered to 6 adult patients each assigned to bare metal stent implantation for single de novo coronary artery lesions, while 8 patients treated with plain contrast medium served as controls. Safety variables and tolerability as well as angiographic parameters were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Device: Implantation of a bare metal stentContrast medium without Paclitaxel |
| Iopromide Paclitaxel 0.85 mg | Active comparator | Device: Implantation of a bare metal stentIopromide Paclitaxel 0.85 mg |
| Iopromide Paclitaxel 4.27 mg | Active comparator | Device: Implantation of a bare metal stentIopromide Paclitaxel 4.27 mg |
| Iopromide Paclitaxel 8.54 mg | Active comparator | Device: Implantation of a bare metal stentIopromide Paclitaxel 8.54 mg |
| Iopromide Paclitaxel 17.08 mg | Active comparator | Device: Implantation of a bare metal stentIopromide Paclitaxel 17.08 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and postmenopausal female patients
- aged 18 years and older
- clinical evidence of stable or unstable angina, a positive functional test and a stentable de novo lesion in a native coronary artery
- diameter stenosis > 70% (visual estimate), lesion length < 25 mm, and a vessel diameter ≥ 2.5 mm.
Key exclusion criteria (12 listed)
- acute myocardial infarction
- left ventricular ejection fraction of < 30%
- aorto-ostial lesion
- unprotected left main lesion or a bypass graft
- clear angiographic calcification in the target lesion
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 |
|---|---|---|
| Implantation of a bare metal stentBare Metal Stent | Device | Iopromide Paclitaxel 0.85 mg, Iopromide Paclitaxel 17.08 mg, Iopromide Paclitaxel 4.27 mg, Iopromide Paclitaxel 8.54 mg, Placebo control |
Primary outcome
Safety of intracoronary application
Time frame: ca. 30 minutes (during intervention)
* Continuous monitoring electrocardiogram (ECG) * Vital signs * Invasive measure of blood pressure * Lab variables: red blood count, white blood count, diff, creatinine kinase, creatinine kinase - muscle bound, creatinine * Cmax of paclitaxel in serum * 12-lead ECG * Adverse events
3 secondary outcomes
Late lumen loss
Time frame: 6 months
Restenosis rate
Time frame: 6 months
Combined clinical endpoints (Major adverse cardiac events, MACE)
Time frame: 6 months
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 27 Apr 2023.
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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.
Bruno Scheller, MD principal investigator
University Hospital, Saarland
Wolfgang Rutsch, MD principal investigator
Charite Hospital, Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Implantation of a bare metal stent in people with Coronary Artery Disease, run by University Hospital, Saarland at 2 sites 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 4 inclusion and 12 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 27 Apr 2023. 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 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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 of intracoronary application (time frame: ca. 30 minutes (during intervention)). 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 27 Apr 2023.