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

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

Condition Intervention Phase
Coronary Artery Disease
Device: Implantation of a bare metal stent
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restenosis Inhibition by Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Late lumen loss [ Time Frame: 6 months ]
    Difference between angiographic in-stent minimum lumen diameter at 6 months follow-up and post-intervention

  • Restenosis rate [ Time Frame: 6 months ]
    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 ]
    1. Abrupt and sub-abrupt closure
    2. Target lesion revascularization
    3. Myocardial infarction
    4. Death

Enrollment: 32
Study Start Date: March 2003
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo control
Contrast medium without Paclitaxel
Device: Implantation of a bare metal stent
Bare Metal Stent
Active Comparator: Iopromide Paclitaxel 0.85 mg
Iopromide Paclitaxel 0.85 mg
Device: Implantation of a bare metal stent
Bare Metal Stent
Active Comparator: Iopromide Paclitaxel 4.27 mg
Iopromide Paclitaxel 4.27 mg
Device: Implantation of a bare metal stent
Bare Metal Stent
Active Comparator: Iopromide Paclitaxel 8.54 mg
Iopromide Paclitaxel 8.54 mg
Device: Implantation of a bare metal stent
Bare Metal Stent
Active Comparator: Iopromide Paclitaxel 17.08 mg
Iopromide Paclitaxel 17.08 mg
Device: Implantation of a bare metal stent
Bare Metal Stent

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01140204

University Hospital of Saarland
Homburg/Saar, Saarland, Germany, 66421
Charite University Hospital
Berlin, Germany, 10117
Sponsors and Collaborators
University Hospital, Saarland
Principal Investigator: Bruno Scheller, MD University Hospital, Saarland
Principal Investigator: Wolfgang Rutsch, MD Charite Hospital, Berlin
  More Information

Responsible Party: Bruno Scheller, MD, University Hospital, Saarland Identifier: NCT01140204     History of Changes
Other Study ID Numbers: 1-325-02
Study First Received: June 7, 2010
Last Updated: June 8, 2010

Keywords provided by University Hospital, Saarland:
contrast media
stent implantation

Additional relevant MeSH terms:
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Albumin-Bound Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017