Moxonidine in Patients Undergoing Vascular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Cardiac Disease Vascular Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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I

moxonidine group

Group Type ACTIVE_COMPARATOR

moxonidine

Intervention Type DRUG

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

II

placebo group

Group Type PLACEBO_COMPARATOR

moxonidine

Intervention Type DRUG

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

Interventions

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moxonidine

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

Intervention Type DRUG

Other Intervention Names

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Physiotens

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No