Moxonidine in Patients Undergoing Vascular Surgery

This study has been terminated.
(Study was stopped after pre-definied interim analysis because of no effects)
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00244504
First received: October 25, 2005
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Cardiac Disease
Vascular Surgery
Drug: moxonidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • over-all mortality [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ischemia detected by Holter-ECG ST alterations or troponin T elevation [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: November 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
moxonidine group
Drug: moxonidine
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Name: Physiotens
Placebo Comparator: II
placebo group
Drug: moxonidine
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Name: Physiotens

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244504

Locations
Switzerland
University hospital
Basel, CH, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Miodrag Filipovic, PD Dr. University Hospital, Basel, Switzerland
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. M. Filipovic, Co-Head of Cardiothoracic Anaesthesia, -
ClinicalTrials.gov Identifier: NCT00244504     History of Changes
Other Study ID Numbers: 158/01
Study First Received: October 25, 2005
Last Updated: November 9, 2009
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Moxonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014