NCT00244504

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

3.3 years

First QC Date

October 25, 2005

Last Update Submit

November 9, 2009

Conditions

Cardiac DiseaseVascular Surgery

Outcome Measures

Primary Outcomes (1)

  • over-all mortality

    30 days and 12 months

Secondary Outcomes (1)

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

    7 days

Study Arms (2)

I

ACTIVE COMPARATOR

moxonidine group

Drug: moxonidine

II

PLACEBO COMPARATOR

placebo group

Drug: moxonidine

Interventions

moxonidineDRUG

moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery

Also known as: Physiotens
III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • abdominal aortic or peripheral vascular surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Basel, CH, 4000, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 17968979DERIVED

MeSH Terms

Conditions

Heart Diseases

Interventions

moxonidine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Miodrag Filipovic, PD Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 26, 2005

Study Start

November 1, 2002

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

CH(1)