Moxonidine in Patients Undergoing Vascular Surgery

November 9, 2009 updated by: University Hospital, Basel, Switzerland

The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery

Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • CH
      • Basel, CH, Switzerland, 4000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • abdominal aortic or peripheral vascular surgery

Exclusion Criteria:

  • unstable angina,
  • severe symptomatic heart failure (NYHA IV)
  • systolic blood pressure at rest < 100 mmHg
  • bradycardia (<50/min)
  • higher grade AV heart block
  • creatinine clearance < 30 ml/min
  • pregnancy
  • no consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I
moxonidine group
Drug: moxonidine
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Names:
  • Physiotens
Placebo Comparator: II
placebo group
Drug: moxonidine
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Names:
  • Physiotens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
over-all mortality
Time Frame: 30 days and 12 months
30 days and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ischemia detected by Holter-ECG ST alterations or troponin T elevation
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Miodrag Filipovic, PD Dr., University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 26, 2005

Study Record Updates

Last Update Posted (Estimate)

November 10, 2009

Last Update Submitted That Met QC Criteria

November 9, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 158/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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