Condition category
Circulatory System
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
02/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.diagram-zwolle.nl

Contact information

Type

Scientific

Primary contact

Mr J Klijn

ORCID ID

Contact details

Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
+31 (0)38 426 2997
j.klijn@diagram-zwolle.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CEZAR

Study hypothesis

The study is designed to demonstrate superiority of Cypher stent based on the assumption that at follow-up angiography the late loss is at least 0.15 mm smaller than the mean late loss when the Taxus stent is used.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute myocardial infarction

Intervention

Percutaneous Coronary Intervention using either the Bx VELOCITYTM stent coated with rapamycin (Cypher) or the TaxusTM stent coated with Paclitaxel.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Major adverse cardiac clinical events (death, re-infarction, target vessel revascularisation) at one, nine and 12 months after treatment.

Secondary outcome measures

Late lumen loss at nine months follow-up by quantitative coronary angiography

Overall trial start date

01/06/2004

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with acute myocardial infarction, presenting within six hours after symptom-onset, or those presenting between six and 24 hours if persisting chest pain associated with clinical evidence of on-going ischaemia occurs
2. Culprit lesion in a native coronary artery, suitable for stenting
3. Lesion length of less than 30 mm, located in a vessel of more than 2.5 mm
4. Able to deliver the stent to target lesion (absence of diffuse disease or excessive proximal vessel tortuosity)
5. Absence of no-reflow or extensive thrombus throughout vessel

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

352

Participant exclusion criteria

1. Women of child-bearing potential
2. Severe hepatic or renal disease
3. Previous participation in the study
4. Life expectancy of less than one year
5. Factors making follow-up difficult
6. Acute myocardial infarction pre-treated with thrombolysis
7. Unprotected left main disease or single remaining vessel
8. Target lesion in a bifurcation with a large side-branch
9. Known sensitivity to aspirin or coumarin
10. Unable to provide informed consent

Recruitment start date

01/06/2004

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Diagram B.V. Zwolle
Zwolle
8011 NB
Netherlands

Sponsor information

Organisation

Isala klinieken (The Netherlands)

Sponsor details

Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
+31 (0)38 424 2374
hof@diagram-zwolle.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes