- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00244504
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
-
-
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
|
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Names:
|
Placebo Comparator: II
placebo group
|
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Names:
|
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.
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.
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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