Moxonidine in Patients Undergoing Vascular Surgery | NCT00244504

Studies
Moxonidine in Patients Undergoing Vascular Surgery

NCT00244504

Sponsor

University Hospital, Basel, Switzerland

Status

Terminated

Last Update Posted

Nov 10, 2009Estimated

Enrollment

141Actual

Phase

Phase 3

Conditions

Cardiac Disease
Vascular Surgery

Interventions

moxonidine

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped after pre-definied interim analysis because of no effects

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Oct 25, 2005

First Submission Date that Met QC Criteria

Oct 25, 2005

First Posted Date

Oct 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2009

Last Update Posted Date

Nov 10, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

141Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Active Comparator	moxonidine group	Drug: moxonidine
II	Placebo Comparator	placebo group	Drug: moxonidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
moxonidine	Drug	moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery	I II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
over-all mortality		30 days and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Ischemia detected by Holter-ECG ST alterations or troponin T elevation		7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miodrag Filipovic, PD Dr.	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital		Basel	CH	4000	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17968979	Derived	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.