Cypher drug-Eluting stent: a Zwolle Acute myocardial infarction Randomised trial

ISRCTN	ISRCTN90526229
DOI	https://doi.org/10.1186/ISRCTN90526229
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr J Klijn
Scientific

Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands

Phone	+31 (0)38 426 2997
Email	j.klijn@diagram-zwolle.nl

Study design	Randomised, active controlled, parallel group, single centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Cypher drug-Eluting stent: a Zwolle Acute myocardial infarction Randomised trial
Study acronym	CEZAR
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2004
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	352
Key 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
Key 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
Date of first enrolment	01/06/2004
Date of final enrolment	01/12/2006

Diagram B.V. Zwolle

Zwolle
8011 NB
Netherlands

Isala klinieken (The Netherlands)
Hospital/treatment centre

Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands

Not defined

Not provided at time of registration

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

20/08/2021: Proactive update review. No publications found. Search options exhausted.