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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-06-30

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo control

Contrast medium without Paclitaxel

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No