Moxonidine in Patients Undergoing Vascular Surgery

Cardiac Disease Clinical Trial

Official title:

The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00244504
• Other study ID #: 158/01
• Status: Terminated
• Phase: Phase 3
• First received: October 25, 2005
• Last updated: November 9, 2009
• Start date: November 2002
• Est. completion date: March 2006

Study information

• Verified date: November 2009
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 141
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Vascular Surgery

Intervention

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

Locations

Country	Name	City	State
Switzerland	University hospital	Basel	CH

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	over-all mortality		30 days and 12 months	No
Secondary	Ischemia detected by Holter-ECG ST alterations or troponin T elevation		7 days	No