Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01140204
First received: June 7, 2010
Last updated: June 8, 2010
Last verified: June 2010

June 7, 2010
June 8, 2010
March 2003
June 2004   (final data collection date for primary outcome measure)
Safety of intracoronary application [ Time Frame: ca. 30 minutes (during intervention) ] [ Designated as safety issue: Yes ]
  • 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
Same as current
Complete list of historical versions of study NCT01140204 on ClinicalTrials.gov Archive Site
  • Late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference between angiographic in-stent minimum lumen diameter at 6 months follow-up and post-intervention
  • Restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Defined as a diameter stenosis of ≥50% (assessed by quantitative coronary angiography) at any control angiography
  • Combined clinical endpoints (Major adverse cardiac events, MACE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    1. Abrupt and sub-abrupt closure
    2. Target lesion revascularization
    3. Myocardial infarction
    4. Death
Same as current
Not Provided
Not Provided
 
Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
Device: Implantation of a bare metal stent
Bare Metal Stent
  • Placebo Comparator: Placebo control
    Contrast medium without Paclitaxel
    Intervention: Device: Implantation of a bare metal stent
  • Active Comparator: Iopromide Paclitaxel 0.85 mg
    Iopromide Paclitaxel 0.85 mg
    Intervention: Device: Implantation of a bare metal stent
  • Active Comparator: Iopromide Paclitaxel 4.27 mg
    Iopromide Paclitaxel 4.27 mg
    Intervention: Device: Implantation of a bare metal stent
  • Active Comparator: Iopromide Paclitaxel 8.54 mg
    Iopromide Paclitaxel 8.54 mg
    Intervention: Device: Implantation of a bare metal stent
  • Active Comparator: Iopromide Paclitaxel 17.08 mg
    Iopromide Paclitaxel 17.08 mg
    Intervention: Device: Implantation of a bare metal stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01140204
1-325-02
Yes
Bruno Scheller, MD, University Hospital, Saarland
University Hospital, Saarland
Not Provided
Principal Investigator: Bruno Scheller, MD University Hospital, Saarland
Principal Investigator: Wolfgang Rutsch, MD Charite Hospital, Berlin
University Hospital, Saarland
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP