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Moxonidine in Patients Undergoing Vascular Surgery

Primary Purpose

Cardiac Disease, Vascular Surgery

Status
Terminated
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
moxonidine
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

I

II

Arm Description

moxonidine group

placebo group

Outcomes

Primary Outcome Measures

over-all mortality

Secondary Outcome Measures

Ischemia detected by Holter-ECG ST alterations or troponin T elevation

Full Information

First Posted
October 25, 2005
Last Updated
November 9, 2009
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00244504
Brief Title
Moxonidine in Patients Undergoing Vascular Surgery
Official Title
The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped after pre-definied interim analysis because of no effects
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Vascular Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
moxonidine group
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
placebo group
Intervention Type
Drug
Intervention Name(s)
moxonidine
Other Intervention Name(s)
Physiotens
Intervention Description
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Primary Outcome Measure Information:
Title
over-all mortality
Time Frame
30 days and 12 months
Secondary Outcome Measure Information:
Title
Ischemia detected by Holter-ECG ST alterations or troponin T elevation
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miodrag Filipovic, PD Dr.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Basel
State/Province
CH
ZIP/Postal Code
4000
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17968979
Citation
Bolliger D, Seeberger MD, Lurati Buse GA, Christen P, Gurke L, Filipovic M. Randomized clinical trial of moxonidine in patients undergoing major vascular surgery. Br J Surg. 2007 Dec;94(12):1477-84. doi: 10.1002/bjs.6012.
Results Reference
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Moxonidine in Patients Undergoing Vascular Surgery

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