Moxonidine in Patients Undergoing Vascular Surgery

Phase 3

Terminated

• Conditions: Cardiac Disease; Vascular Surgery
• Interventions: Drug: moxonidine

• Registration Number: NCT00244504
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-26
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 141

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II	moxonidine	placebo group
I	moxonidine	moxonidine group

Primary Outcome Measures

Name	Time	Method
over-all mortality	30 days and 12 months

Secondary Outcome Measures

Name	Time	Method
Ischemia detected by Holter-ECG ST alterations or troponin T elevation	7 days

Trial Locations

Locations (1)

University hospital; 🇨🇭 Basel, CH, Switzerland