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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014