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

NCT01140204 | Completed Phase 1 DMC

• 1 other identifier: 1-325-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

stent; contrast media; paclitaxel; stent implantation

Outcome Measures

Primary Outcomes (1)

• 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

  ca. 30 minutes (during intervention)

Secondary Outcomes (3)

• Late lumen loss

  6 months

• Restenosis rate

  6 months

• Combined clinical endpoints (Major adverse cardiac events, MACE)

  6 months

Study Arms (5)

Placebo control

PLACEBO COMPARATOR

Contrast medium without Paclitaxel

Device: Implantation of a bare metal stent

Iopromide Paclitaxel 0.85 mg

ACTIVE COMPARATOR

Iopromide Paclitaxel 0.85 mg

Device: Implantation of a bare metal stent

Iopromide Paclitaxel 4.27 mg

ACTIVE COMPARATOR

Iopromide Paclitaxel 4.27 mg

Device: Implantation of a bare metal stent

Iopromide Paclitaxel 8.54 mg

ACTIVE COMPARATOR

Iopromide Paclitaxel 8.54 mg

Device: Implantation of a bare metal stent

Iopromide Paclitaxel 17.08 mg

ACTIVE COMPARATOR

Iopromide Paclitaxel 17.08 mg

Device: Implantation of a bare metal stent

Interventions

Implantation of a bare metal stent DEVICE

Bare Metal Stent

Iopromide Paclitaxel 0.85 mg; Iopromide Paclitaxel 17.08 mg; Iopromide Paclitaxel 4.27 mg; Iopromide Paclitaxel 8.54 mg; Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (2)

University Hospital of Saarland

Homburg/Saar, Saarland, 66421, Germany

Location

Charite University Hospital

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bruno Scheller, MD

  University Hospital, Saarland

  PRINCIPAL INVESTIGATOR

• Wolfgang Rutsch, MD

  Charite Hospital, Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: March 1, 2003
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

DE (2)