|- candidate number||1175|
|- NTR Number||NTR110|
|- Date ISRCTN created||12-sep-2005|
|- date ISRCTN requested||18-aug-2005|
|- Date Registered NTR||4-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||Cypher drug-Eluting stent: A Zwolle AMI Randomized trial.|
|- Scientific Title||Comparative Randomized Trial of Rapamycin versus Paclitaxel-eluting stent in AMI.|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Acute myocardial infarction |
|- Inclusion criteria||1. Patients with acute myocardial infarction, presenting within 6 hours after symptom-onset, or those presenting between 6 and 24 hours if persisting chest pain associated with clinical evidence of on-going ischemia occurs;|
2. Culprit lesion in a native coronary artery, suitable for stenting;
3. Lesion length of < 30 mm, located in a vessel of > 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.
|- Exclusion criteria||1. Women of child-bearing potential;|
2. Severe hepatic or renal disease;
3. Previous participation in the study;
4. Life expectancy of < 1 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2004|
|- planned closingdate||1-dec-2006|
|- Target number of participants||352|
|- Interventions||Percutane Coronaire Interventie.|
|- Primary outcome||Major adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 1, 9 and 12 months after treatment.
|- Secondary outcome||Late lumen loss at 9 months follow-up by quantitative coronary angiography.|
|- Trial web site||http://www.diagram-zwolle.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| J. Klijn|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Harry Suryapranata|
|- Sponsor/Initiator ||Isala Klinieken, Locatie Weezenlanden, Department of Cardiology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Title of Study:|
Cypher drug-Eluting stent.
A Zwolle AMI Randomized trial
To compare Rapamycin vs Paclitaxel - eluting stent, in patients with acute myocardial infarction.
Single-center, prospective, randomized trial
Randomized Phase III.
- Bx VELOCITYTM stent coated with rapamycin (Cypher)
- TaxusTM , stent coated with Paclitaxel.
Diagnosis and criteria for inclusion Patients with acute myocardial infarction, scheduled for emergency coronary angioplasty.
Intended use of the devices to achieve an increased lumen diameter of a (re) stenosis or occlusion in a coronary artery, which allows improved perfusion and performance.
352 patients with acute myocardial infarction.
Clinical and angiographic data will be analyzed both according to the principle of intention-to-treat and evaluable group analyses. End-point variables will be presented by means of 95% confidence intervals for the mean difference for quantitative results. An estimate of the relative risk for the treatment groups and the 95% confidence interval of the risk will be provided for 9-month restenosis rate and each of the adverse event parameters. Besides descriptive techniques the actuarial life table method will be used for analyzing occurrence of the adverse events and target vessel revascularization during the one-year follow-up period.
Primary Endpoints: -Late loss at 9 month follow-up by quantitative coronary angiography.
-Major adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 1, 9 and 12 months after treatment.
|- Main changes (audit trail)|
|- RECORD||4-aug-2005 - 14-sep-2009|